BJA Advance Access originally published online on July 6, 2007
British Journal of Anaesthesia 2007 99(4):576-580; doi:10.1093/bja/aem096
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Postoperative nausea, vomiting, airway morbidity, and analgesic requirements are lower for the ProSeal laryngeal mask airway than the tracheal tube in females undergoing breast and gynaecological surgery
1 Department of Anaesthesia and Intensive Care Medicine, Medical University Innsbruck, Austria
2 Department of Anaesthesia and Intensive Care, Cairns Base Hospital, James Cook University, The Esplanade, Cairns 4870, Australia
* Corresponding author. E-mail: jbrimaco{at}bigpond.net.au
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Abstract |
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Background: We test the hypothesis that the frequency of postoperative nausea and vomiting is similar for the ProSeal laryngeal mask airway (LMA) and the tracheal tube.
Methods: Two hundred consecutive female patients (ASA I–II, 18–75 yr) undergoing routine breast and gynaecological surgery were divided into two equal-sized groups for airway management with the ProSeal LMA or tracheal tube.
Results: Ventilation was better and airway trauma less frequent for the ProSeal LMA. For the ProSeal group, the time spent in the post-anaesthesia care unit was shorter (69 vs 88 min, P < 0.0001); fewer doses of tropisetron were required in the post-anaesthesia care unit (P 
0.001) and ward (P = 0.004); morphine requirements were lower in the post-anaesthesia care unit (6.0 vs 8.1 mg, P = 0.005) and ward (6.1 vs 8.9, P = 0.004); nausea was less frequent at all times (overall: 13% vs 53%, P < 0.0001); vomiting was less frequent at 2 h (4% vs 18%, P = 0.003) and 24 h (5% vs 19%, P = 0.004); and sore throat was less frequent at all times (overall: 12% vs 38%, P < 0.0001).
Conclusions: The ProSeal LMA reduced the absolute risk of postoperative nausea and vomiting by 40% (53–13%). In patients without the need for morphine, the ProSeal LMA reduced the absolute risk of postoperative nausea and vomiting by 23% (37–14%). We conclude that the frequency of postoperative nausea, vomiting, airway morbidity, and analgesic requirements is lower for the ProSeal LMA than the tracheal tube in females undergoing breast and gynaecological surgery.
Keywords: complications, sore throat; vomiting, nausea
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Introduction |
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Postoperative nausea and vomiting occurs in approximately one-third of untreated surgical patients.1 In addition to being highly unpleasant, it can cause delays in discharge from the post-anaesthesia care unit, unexpected readmission to hospital, and, more seriously, aspiration, wound dehiscence, and oesophageal rupture.2 In principle, the choice of airway device might influence postoperative nausea and vomiting as different portions of the airway are stimulated. Two studies have shown that postoperative nausea and vomiting is more frequent for the laryngeal mask airway (LMA
) (extraglottic location) than the tracheal tube (subglottic location)3 4 and one that it is more frequent for the tracheal tube.5 The ProSeal LMA (Laryngeal Mask Company, Henley-on-Thames, UK) is a relatively new extraglottic airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation, and insertion of a gastric tube.6 7 In the following randomized prospective double-blind trial, we test the hypothesis that the frequency of postoperative nausea and vomiting is similar for the ProSeal LMA and the tracheal tube. |
Methods |
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Two hundred consecutive female patients (American Society of Anesthesiologists grade I–II, 18–75 yr) undergoing elective specific breast (lumpectomy; lumpectomy and axillary clearance of sentinel node) and gynaecological laparoscopic surgery (diagnostic, uni- and bilateral ovarian resection, ovarian cyst resection, and fibroidectomy) in the supine position were studied. Ethical committee approval and written informed consent were obtained. Patients were excluded from the trial if they had a known or predicted difficult airway, oropharyngeal pathology, mouth opening < 3.0 cm, a body mass index > 35 kg m–2, were at increased risk of aspiration, had nausea/vomiting/sore throat within 24 h of surgery, or had been given anti-emetics within 24 h of surgery. Patients were randomly allocated to two equal-sized groups: in one group airway management was done with a tracheal tube and in the other with a ProSeal LMA. Randomization was by computer-generated numbers and allocation by opening a sealed opaque envelope immediately before surgery. All cases were performed by anaesthetists with 3–5 years training under the direct supervision of one of the investigators (C.K.).
Patients were premedicated with midazolam 0.05–0.1 mg kg–1 orally 1 h before operation. A standard anaesthesia protocol was followed and routine monitoring applied. The head/neck was on a standard pillow 7 cm in height. Anaesthesia was induced with fentanyl 2–4 µg kg–1 and propofol 2.5–3.0 mg kg–1. Anaesthesia was maintained with isoflurane 1% in O2 33% and air. Neuromuscular block was achieved by rocuronium 0.6 mg kg–1. Patients' lungs were ventilated via a face mask for 3 min until the train-of-four ratio was 0. The airway devices [size ID 7.0 mm for tracheal tube (Mallinckrodt Medical, Athlone, Ireland) and size 4 for ProSeal LMA] were used in strict accordance with their respective manufacturer's recommendations. No prophylactic anti-emetics were given. Tracheal intubation involved (i) obtaining the best possible view of the vocal cords with a Macintosh laryngoscope blade and (ii) inserting the tracheal tube through the vocal cords into the trachea. ProSeal LMA insertion involved (i) obtaining the best possible view of the hypopharynx with a Macintosh laryngoscope blade; (ii) inserting a gum elastic bougie with its straight end first through the hypopharynx into the proximal 5 cm of the oesophagus; and (iii) railroading the ProSeal LMA along its drain tube into the pharynx. A maximum of two attempts was allowed to obtain an effective airway. A failed attempt was defined as removal of the device from the mouth. An effective airway was defined as two consecutive breaths with an expired tidal volume 
6 ml kg–1. Insertion was considered to have failed if an effective airway was not obtained after two attempts. Both devices were fixed by taping the tube in the midline over the chin.
Once an effective airway was obtained, the intracuff pressure was set and held constant at 20 cm H2O for the tracheal tube and 60 cm H2O for the ProSeal LMA using a digital manometer (Mallinckrodt Medical, Athlone, Ireland). A well-lubricated 60 cm long (14 F) orogastric tube was inserted using laryngoscope-guidance in the tracheal tube group and using the drain tube in the ProSeal group. A maximum of two attempts was allowed. Correct gastric tube placement was assessed by suction of fluid or detection of injected air by epigastric stethoscopy.8 A clear, water-based jelly (K-Y Lubricating Jelly, Johnson and Johnson, Maidenhead, UK) was used to lubricate the airway devices and gastric tubes. The gastric tube was suctioned after insertion and before removal and was left on free drainage in between.
During the maintenance phase, patients' lungs were pressure-controlled ventilated (Draeger Julian, Draeger, Lubeck, Germany) with a peak airway pressure set at 15 cm H2O, a PEEP set at 5 cm H2O, a respiratory rate of 12 min–1, a inspiratory flow rate of 50 litre min–1 and a fresh gas flow of 1.5 litre min–1. During pneumoperitoneum, peak airway pressures were increased to maintain E'CO2 at 40 mm Hg. Ringer's Lactate solution was administered at a rate of 10–15 ml kg–1 h–1. Blood loss was replaced with Hetastarch at a 1:1 ratio to maintain normal intravascular volume. Diclofenac 75 mg i.v. was given to all patients during surgery and 12 h after operation, unless they had an allergy to non-steroidal anti-inflammatory drugs or a history of gastric ulcers. Forced air warming system was used to keep the rectal temperature near 37°C.
Muscle relaxation was reversed at the end of surgery with neostigmine 1–2.5 mg and atropine 0.5–1.0 mg if the train-of-four ratio was less than 0.8. The tracheal tube, ProSeal LMA, and gastric tube were removed when the patient was spontaneously breathing and able to open their mouth to command. Any blood staining on the laryngoscope, tracheal tube, or ProSeal LMA was documented. The total residual gastric volume was recorded.
Patients were assessed for pain (yes/no), nausea (yes/no), and vomiting (yes/no) every 5 min in the post-anaesthesia care unit and every 2 h on the ward by a nurse blinded to the airway device used. In the post-anaesthesia care unit, all types of postoperative pain were treated with i.v. morphine in 1–2 mg increments. In the ward, all types of postoperative pain were treated with i.m. morphine 2.5–7.5 mg every 3–4 h. In the post-anaesthesia care unit, all types of nausea and vomiting were treated with tropisetron 1 mg i.v. as the first line agent and droperidol 1.25 mg i.v. as the second line agent. Patients were discharged from the post-anaesthesia care unit when they were awake, haemodynamically stable, had no pain/nausea/vomiting, and when the SpO2 was > 95% on air.
Patients and post-anaesthesia care unit nurses were unaware of the airway device used. A single trained observer, who was blinded to the airway device used, documented the adverse events at 2, 6, and 24 h after surgery. At the interview, patients were asked if they had any of the following symptoms (yes/no): nausea, vomiting (at any time since last interview), sore throat (constant pain, independent of swallowing), dysphonia (difficulty speaking and pain on speaking), and dysphagia (difficulty or pain provoked by swallowing). Anaesthesia time was from pre-oxygenation to removal of the airway device. Surgical time was from incision to insertion of the last stitch. Cardiorespiratory data were collected every 5 min. Any episodes of bradycardia (< 40 min–1), tachycardia > 100 min–1, or systolic hypotension (< 80 mm Hg) were documented. Any episodes of hypoxia (SpO2 < 90%) were documented.
Sample size was based on a projected difference of 25% between the groups for nausea, a type I error of 0.05, and a power of 0.90, and was based on a 60% incidence of nausea.2 9 10 If the randomized device failed and the alternative device succeeded, all variables were assigned to the initial randomized device (intention to treat). The distribution of data was determined using Kolmogorov–Smirnov analysis.11 Statistical analysis of the outcome parameters was with ANOVA for repeated measurements. In the case of a significant difference, further comparisons were made with paired t-test or Fisher's exact test between groups at individual time points. The Bonferroni–Holm procedure was used for corrections of multiple comparisons. Significance was taken as P < 0.05.
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Results |
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There were no important differences in patient characteristics or surgical data (Table 1). Anaesthesia characteristics were mostly similar, but tidal volume was higher and end-tidal CO2 lower in the ProSeal group. There were no other differences in cardiorespiratory data. Hypoxia did not occur in either group. There were no differences in the dose of propofol [tracheal tube vs ProSeal LMA; 193 (37) vs 198 (30) mg], fentanyl [0.39 (0.14) vs 0.36 (0.14) mg], and isoflurane [1.01 (0.16) vs 1.01 (0.14) end tidal %]. Diclofenac was given to a similar number of patients in each group (81 vs 89). The cumulative volumes of crystalloids [1250 (399) vs 1190 (486) ml] and colloids [575 (245) vs 533 (129) ml] were similar. Blood was detected more frequently on the tracheal tube. The total residual gastric volume was similar [tracheal tube vs ProSeal LMA; 13.7 (24.1) vs 14.0 (19.3) ml]. Outcome data are presented in Table 2. For the ProSeal group, (i) the time spent in the post-anaesthesia care unit was shorter (69 vs 88 min, P < 0.0001); (ii) fewer doses of tropisetron were required in the post-anaesthesia care unit (P
0.001) and ward (P = 0.004); (iii) morphine requirements were lower in the post-anaesthesia care unit (6.0 vs 8.1 mg, P = 0.005) and ward (6.1 vs 8.9, P = 0.004); (iv) nausea was less frequent at all times (overall: 13% vs 53%, P < 0.0001); (v) vomiting was less frequent at 2 h (4% vs 18%, P = 0.003) and 24 h (5% vs 19%, P = 0.004); and (vi) sore throat was less frequent at all times (overall: 12% vs 38%, P < 0.0001). The ProSeal LMA reduced the absolute risk of postoperative nausea and vomiting by 40% (53–13%; 95% CI 37–44%). In patients without the need for morphine, the ProSeal LMA reduced the absolute risk of postoperative nausea and vomiting by 23% (37–14%; 95% CI 20–26%) (Table 3). To prevent one patient suffering from postoperative nausea, vomiting, and sore throat, four patients are required to be managed with the ProSeal LMA rather than the tracheal tube.
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Discussion |
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We found that the ProSeal LMA reduces the absolute risk of postoperative nausea and vomiting by 40% and 14%, respectively, compared with the tracheal tube. There are three previous studies providing information about this topic. Previously, investigators3 4 revealed that there was more postoperative nausea and vomiting with the LMA than the tracheal tube in the first 4–6 h; however, Klockgether-Radke and colleagues5 found that postoperative nausea and vomiting was lower with the LMA than with the tracheal tube. These interstudy differences are difficult to explain, but may in part be related to the use of a gastric tube with the ProSeal LMA. Also, postoperative nausea and vomiting was not the primary variable in these previous studies.
Our study has a number of limitations. First, our study population was not entirely homogenous in that half the patients were undergoing laparoscopic surgery and half breast surgery.12 However, the type of breast and gynaecological surgery was specific and breakdown of data for these subgroups and specific surgeries revealed no differences. Secondly, ventilation was more effective for the ProSeal LMA than the tracheal tube, and in principle, it is possible that this may have contributed to differences in postoperative nausea, vomiting, and analgesia. However, this is unlikely as there is no known link between intraoperative end-tidal CO2 and postoperative nausea/vomiting/analgesia. Furthermore, the end-tidal CO2 for the tracheal tube was still in the normal range. Thirdly, the ProSeal LMA was inserted using a guided technique, which has a very high first attempt insertion success rate, and our data, particularly for airway morbidity, may not apply to the less successful digital and introducer tool insertion techniques. Fourthly, we used a yes/no response as the tool to measure pain and nausea. A scoring system for these parameters would have allowed more accurate and useful data collection. Finally, our data may not apply to other patient populations undergoing other surgical procedures. However, as our findings were similar for breast and laparoscopic surgery, it is likely that our findings hold true for healthy females undergoing elective surgery.
The ProSeal LMA reduced the need for postoperative morphine by approximately 25%. Two groups have shown that postoperative analgesic requirements are lower for the classic LMA than the tracheal tube.13 14 As in our study, postoperative analgesia was not the primary variable in either of these studies. We found that postoperative analgesic requirements were similar for patients with and without airway morbidity, suggesting that the reduction in analgesic requirement was not related to reduced airway morbidity with the ProSeal LMA. Also, only half of the reduction in postoperative nausea and vomiting could be attributed to lower morphine requirements. We speculate that the ProSeal LMA may have a pre-emptive analgesic and anti-emetic effect. The presence of a cuff in the pharynx is much less stimulating than a cuff in the trachea.15 Perhaps, the decreased airway stimulation somehow raises the threshold for postoperative pain, nausea, and vomiting. This mechanism is perhaps similar to the pre-emptive analgesic effect at the spinal level produced during regional anaesthesia.16
The ProSeal LMA reduced the absolute risk of postoperative sore throat and dysphagia by 26% and 12%, respectively. The frequency of airway morbidity was similar to that found in previous studies with the ProSeal LMA.7 17 Although it is well established that the incidence of airway morbidity is lower for the classic LMA than the tracheal tube (39% vs 17%),18 there is only one study comparing airway morbidity for the ProSeal LMA and tracheal tube, and this showed no difference in 104 patients undergoing gynaecological laparoscopy.19 Mucosal pressures are similar to those of the classic LMA for a given cuff volume, but are lower for a given seal.20 In principle, the ProSeal LMA might have lower airway morbidity than the classic LMA; however, unguided insertion is more difficult and might counteract the beneficial effects of reduced mucosal pressures. Most studies report similar airway morbidity,7 21 but one group reported a higher frequency with the ProSeal LMA.22 Guided insertion techniques, such as the use of a gum elastic bougie, have higher insertion success rates and cause less airway trauma, and might be expected to have a lower incidence of airway morbidity.23 Interestingly, two studies have shown that there is no correlation between the presence of symptoms of pharyngolaryngeal discomfort and patient satisfaction after LMA anaesthesia.24 25
The ProSeal LMA provided better ventilation than the tracheal tube for a given peak airway pressure. This supports the findings of Voyagis and colleagues26 27 who found that tidal volumes were higher for the classic LMA than the tracheal tube for a given peak inspiratory pressure. In principle, this could be related to reduced resistance to gas flow along the device or within the lungs or both; however, it is likely to be related to reduced pulmonary airway resistance, as the internal diameter of the ProSeal LMA airway tube is similar to that of the tracheal tube and the glottis, which normally contributes up to 25% of total airway resistance,28 is not bypassed. There is evidence that pulmonary airway resistance is lower for the classic LMA than for the tracheal tube.29 30
We conclude that the frequency of postoperative nausea, vomiting, airway morbidity, and analgesic requirements is lower for the ProSeal LMA than for the tracheal tube in females undergoing breast and gynaecological laparoscopic surgery.
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Acknowledgement |
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This project was supported solely by departmental resources.
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Footnotes |
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Declaration of interest. Drs J. Brimacombe and C. Keller have worked as consultants for the laryngeal mask company. 
LMA® is the property of Intavent Ltd.
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References |
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3 Swann DG, Spens H, Edwards SA, Chestnut RJ. Anaesthesia for gynaecological laparoscopy—a comparison between the laryngeal mask airway and tracheal intubation. Anaesthesia (1993) 48:431–4.[Web of Science][Medline]
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18 Brimacombe J. Problems. In: Laryngeal Mask Anesthesia. Principles and Practice—Brimacombe J, ed. (2005) 2nd edn. London: WB Saunders. 551–76.
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29 Berry A, Brimacombe J, Keller C, Verghese C. Pulmonary airway resistance with the endotracheal tube versus laryngeal mask airway in paralyzed anesthetized adult patients. Anesthesiology (1999) 90:295–7.
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