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

The Impact of Moderate Versus Deep Neuromuscular Blockade on Enhanced Recovery After Bariatric Anesthesia: A Randomized Double Blinded Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Device: Neuromuscular transmission monitoring (NMT)

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11472
    • King Saud University College of Medicine and King Khalid University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; 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.	Device: Neuromuscular transmission monitoring (NMT); NMT is to monitor the depth of neuromuscular blockade intensity; Other Names: NMT monitor the depth of muscle relaxation and based upon its reading Rocuronium which is muscle relaxant to be given to the patient under general anesthesia
Experimental: group B; 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.	Device: Neuromuscular transmission monitoring (NMT); NMT is to monitor the depth of neuromuscular blockade intensity; Other Names: NMT monitor the depth of muscle relaxation and based upon its reading Rocuronium which is muscle relaxant to be given to the patient under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete recovery in post anesthesia care unit (PACU) without residual curarization	clinical signs of recovery are met in the PACU	immediate postoperative in the PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete recovery in the ward	clinical signs of recovery are met in the ward	first postoperative day

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: ALHARBI, KindSaudU

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: E-19-3960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: to be submit
• IPD Sharing Time Frame: i year
• IPD Sharing Access Criteria: to be submit
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No