Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

NCT02812186 | Completed Phase 4 Results

• 1 other identifier: 823925
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Conditions

Cholecystitis; Endometriosis; Bowel Obstruction; Fibroids; Prostate Cancer; Chronic Kidney Disease; Uterine Prolapse

Keywords

Neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Peak Airway Pressures

  To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB

  Intra-operative, from intubation time to extubation time

Secondary Outcomes (2)

• Abdominal Insufflation Pressure

  Intra-operative, from intubation time to extubation time

• Surgical Rating Scale

  Intra-operative, from intubation time to extubation time

Study Arms (2)

Deep to Moderate NMB

OTHER

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

Procedure: Deep to Moderate NMB; Drug: Rocuronium

Moderate to Deep NMB

OTHER

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

Procedure: Moderate to Deep NMB; Drug: Rocuronium

Interventions

Deep to Moderate NMB PROCEDURE

Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.

Deep to Moderate NMB

Moderate to Deep NMB PROCEDURE

Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.

Moderate to Deep NMB

Rocuronium DRUG

Deep to Moderate NMB; Moderate to Deep NMB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must be willing and able to provide written informed consent for the study.
• Each participant must be American Society of Anesthesiologists (ASA) class I, II or III.
• Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery).
• Expected surgical duration of 60 min or longer

You may not qualify if:

• Inability to give informed oral or written consent
• Known or suspected neuromuscular disorders impairing neuromuscular function;
• True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids
• A history (patient or family) of malignant hyperthermia
• A contraindication for neostigmine administration
• Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level
• Body mass index \>40 kg/m\^2
• Significant respiratory disease.
• Planned postoperative mechanical ventilation

Sponsors & Collaborators

• Stony Brook University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Cholecystitis; Endometriosis; Intestinal Obstruction; Leiomyoma; Prostatic Neoplasms; Renal Insufficiency, Chronic; Uterine Prolapse

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Intestinal Diseases; Gastrointestinal Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Ruchir Gupta
• Organization: Stony Brook University

gupta2005@yahoo.com

917-443-1263

Study Officials

• Ruchir Gupta, MD

  Stony Brook Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 24, 2016
• Study Start: December 27, 2016
• Primary Completion: January 17, 2019
• Study Completion: February 6, 2019
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)