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

NCT04466943 | Unknown

• 1 other identifier: E-19-3960
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complete recovery in the ward

  first postoperative day

Study Arms (2)

group A

EXPERIMENTAL

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)

group B

EXPERIMENTAL

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)

Interventions

Neuromuscular transmission monitoring (NMT) DEVICE

NMT is to monitor the depth of neuromuscular blockade intensity

Also known as: 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

group A; group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of allergy to Rocuronium or Sugammadex.
• History of allergy to Dexamethasone, Ondansetron, Paracetamol, Fentanyl, Propofol, Morphine or Tramadol.
• Current or previous pregnancy.
• 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
• Patient on oxygen therapy , e,g CPAP

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University College of Medicine and King Khalid University Hospital

Riyadh, 11472, Saudi Arabia

Location

Study Officials

• ALHARBI

  KindSaudU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the attending anesthesiologist and anesthesia assistant are going to be aware of the allocation in order to administer the required level of NMB
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 10, 2020
• Study Start: January 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: i year
• Access Criteria: to be submit

Locations

SA (1)