Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

NCT02635542 | Completed Phase 4 Results DMC

• 1 other identifier: 15-1016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a prospective, randomized trial to assess the impact of neuromuscular blockade on early (\<72 hours post-ICU admission) postoperative respiratory complications in cardiac surgical patients. The study will compare continual neuromuscular blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for cardiac surgery.

Conditions

Neuromuscular Blockade; Postoperative Complications

Keywords

Postoperative Pulmonary Complications; Residual Neuromuscular Blockade; Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Pulmonary Complications

  Having at least one of the following complications, determined according to pre-specified criteria: extubation delayed \>24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.

  72 hours following surgical procedure

Secondary Outcomes (1)

• Surgical Conditions

  During general anesthesia

Study Arms (2)

Group CIS

ACTIVE COMPARATOR

Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).

Drug: Cisatracurium

Group SUX

EXPERIMENTAL

A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.

Drug: Succinylcholine

Interventions

Succinylcholine DRUG

Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.

Also known as: Suxamethonium

Group SUX

Cisatracurium DRUG

Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.

Also known as: Nimbex

Group CIS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass

You may not qualify if:

• Emergency surgery
• Extremes of age
• Previous cardiac surgery
• Clinical contraindications to succinylcholine or cisatracurium
• Anticipated difficult tracheal intubation
• Preoperative mechanical ventilation
• Preoperative pharmacologic/mechanical hemodynamic support

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Postoperative Complications; Delayed Emergence from Anesthesia

Interventions

Succinylcholine; cisatracurium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Results Point of Contact

• Title: Rebecca M Gerlach, MD
• Organization: University of Chicago

rgerlach@dacc.uchicago.edu

773-702-6700

Study Officials

• Rebecca M Gerlach, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Open label drug administration. Outcomes assessor and care providers are otherwise masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: March 1, 2016
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06

Locations

US (1)