Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

NCT ID: NCT02812186

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-27
• Study Completion Date: 2019-02-06

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.

Detailed Description

Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.

Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.

Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Deep to Moderate NMB

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.

Group Type: OTHER

Deep to Moderate NMB

Intervention Type: 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.

Rocuronium

Intervention Type: DRUG

Moderate to Deep NMB

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.

Group Type: OTHER

Moderate to Deep NMB

Intervention Type: 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.

Rocuronium

Intervention Type: DRUG

Interventions

Deep to Moderate NMB

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.

Intervention Type: PROCEDURE

Moderate to Deep NMB

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.

Intervention Type: PROCEDURE

Rocuronium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Ruchir Gupta

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruchir Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

823925

Identifier Type: -

Identifier Source: org_study_id