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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04466943
Enrollment
110
Registered
2020-07-10
Start date
2020-01-01
Completion date
2020-12-31
Last updated
2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate

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.

Interventions

DEVICENeuromuscular transmission monitoring (NMT)

NMT is to monitor the depth of neuromuscular blockade intensity

Sponsors

King Saud University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Only the attending anesthesiologist and anesthesia assistant are going to be aware of the allocation in order to administer the required level of NMB

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complete recovery in post anesthesia care unit (PACU) without residual curarizationimmediate postoperative in the PACUclinical signs of recovery are met in the PACU

Secondary

MeasureTime frameDescription
Complete recovery in the wardfirst postoperative dayclinical signs of recovery are met in the ward

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026