The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia

Not Applicable

• Conditions: Bariatric Surgery Candidate
• Interventions: Device: Neuromuscular transmission monitoring (NMT)

• Registration Number: NCT04466943
• Lead Sponsor: King Saud University

Brief Summary

Most published articles suggest that deep neuromuscular blockade is required for bariatric surgery. However, the evidence for such practice is still inconclusive. From the clinical experience at a major bariatric center of volume exceeding six hundred procedures annually, the investigators believe that moderate neuromuscular blockade will provide an adequate surgical condition and significantly facilitate enhanced recovery after bariatric procedures.

Detailed Description

Muscle relaxation is paramount for successful laparoscopic surgery. However the optimal degree of neuromuscular blockade (NMB) is not identified yet. Previous studies showed conflicting results on the outcomes of laparoscopic surgical conditions when moderate NMB was compared to deep blockade .The evidence for the use of either modalities is rather limited . In the recent literature, there is insufficient evidence to conclude that deep NMB improves surgical conditions during laparoscopic bariatric surgery.

In the recent literature, there is insufficient evidence to conclude that deep NMB improves surgical conditions during laparoscopic bariatric surgery. However postoperative pulmonary function was decreased independently of the depth of NMB regime. There are limited data on the effect of such practices on postoperative outcomes especially in enhanced recovery after bariatric anesthesia (ERABA) .A previous study by Unterbuchner C has showed deep NMB may improve surgical conditions during low-pressure capnoperitoneium , However ,it has also been reported by M.H. Bruintjes and his colleagues showed that the routine capnoperitoneium insufflation pressure improved surgical conditions independent of the level of muscular relaxation. Torensma B and his colleagues have reported that the previous pregnancy can affects the abdominal wall strength and eventually the degree of relaxation Therefore, the investigators have decided to exclude any females with previous history of pregnancy in the study design and also report interaction between inhalation anesthetics and NMB, through augmentation of the effect of NMB.

Martini and his colleagues showed that , rating of the quality of surgical conditions considerably varies between different surgeons when assessed through Leiden-Surgical-Rating-scale . Therefor in this study, the Lieden-surgical-score is going to be used by the bariatric surgeon who is going to be the operating consultant in this study population.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-06-29
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Age older than 18 years.
2. Obese or morbidly obese as defined by a BMI > 35 (kg/m2).
3. American Society of Anesthesiologists physical status class II, or III.
4. Presenting of Laparoscopic sleeve gastrectomy.

Exclusion Criteria

1. History of allergy to Rocuronium or Sugammadex.
2. History of allergy to Dexamethasone, Ondansetron, Paracetamol, Fentanyl, Propofol, Morphine or Tramadol.
3. Current or previous pregnancy.
4. History of renal impairment, (We are going to use the Cockcroft-Gault equation is the gold standard for estimating renal function for the purposes of drug dosing cut off point: CrCl/GFR=30ml/min) The GFR calculator is available at: http://clincalc.com/Kinetics/CrCl.aspx?example
5. Patient on oxygen therapy , e,g CPAP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Neuromuscular transmission monitoring (NMT)	Deep NMB, defined by (0 twitch count in the TOF, 1±2 twitch responses in the post-tetanic count. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.
group A	Neuromuscular transmission monitoring (NMT)	Moderate neuromuscular blockade (NMB) , defined as a 1±2 twitch response to the train-of four (TOF) by stimulation of the ulnar nerve. The device which will be used is neuromuscular transmission monitor (NMT) to test the depth of muscle relaxation after giving rocuronium which is a muscle relaxant during general anesthesia.

Primary Outcome Measures

Name	Time	Method
Complete recovery in post anesthesia care unit (PACU) without residual curarization	immediate postoperative in the PACU	clinical signs of recovery are met in the PACU

Secondary Outcome Measures

Name	Time	Method
Complete recovery in the ward	first postoperative day	clinical signs of recovery are met in the ward

Trial Locations

Locations (1)

King Saud University College of Medicine and King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia