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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04466943
• Other study ID #: E-19-3960
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Device:
• Neuromuscular transmission monitoring (NMT)
NMT is to monitor the depth of neuromuscular blockade intensity

Locations

Country	Name	City	State
Saudi Arabia	King Saud University College of Medicine and King Khalid University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete recovery in the ward	clinical signs of recovery are met in the ward	first postoperative day