Avoiding Neuromuscular Blockers to Reduce Complications

Ketamine

Brief Summary

The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.

Intervention / Treatment

Neuromuscular Blocking Agents (DRUG)

Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
Anesthetic Adjuncts (DRUG)

Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.

Condition or Disease

Respiratory Failure
Respiratory Infection
Aspiration Pneumonia
Pneumonitis
Atelectasis
Bronchospasm

Phase

Phase 4

Study Design

Study type:	INTERVENTIONAL
Status:	Terminated
Study results:	No Results Available
Age:	18 Years and older (Adult, Older Adult)
Enrollment:	3 (ACTUAL)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Treatment
Masking DOUBLE: Participant Outcomes Assessor

Clinical Trial Dates

Start date:	Aug 07, 2019	ACTUAL
Primary Completion:	Dec 19, 2022	ACTUAL
Completion Date:	Dec 19, 2022	ACTUAL
Study First Posted:	May 24, 2019	ACTUAL
Results First Posted:	Aug 31, 2020
Last Updated:	Jan 31, 2023

Sponsors / Collaborators

Lead Sponsor: Beth Israel Deaconess Medical Center

Responsible Party: N/A

Location

Boston, Massachusetts, USA

Pragmatic prospective randomized controlled assessor-blinded effect-size finding trial involving approximately 100 patients total at two academic tertiary care hospitals: Beth Israel Deaconess Medical Center (BIDMC) and Massachusetts General Hospital (MGH). Patients will be randomized into one of two study groups: standard care group which uses Rocuronium (NMBA) as an adjunct for maintenance of general anesthesia and non-relaxant arm that avoids the use of NMBA and instead uses additional inhalational anesthetics, opioids, propofol, dexmedetomidine, or ketamine for maintenance of general anesthesia. Assessment of postoperative pulmonary complications and in-hospital mortality would be achieved by close review of the patient's medical records during the hospital stay, for a maximum of 28 days.

Participant Groups

Endotracheal intubation would be facilitated by either Rocuronium (0.6-1mg kg-1) or Succinylcholine (1-1.5mg kg-1) and further dosing of Rocuronium would be left at the discretion of the anesthesia team members. Choice and technique of induction and maintenance of anesthesia, use of vasopressors, perioperative antibiotics, analgesics/adjunct regional techniques, prophylaxis for postoperative nausea and vomiting, fluid and blood component therapy would be left at the discretion of the anesthesia team. Neuromuscular blockade would be reversed with either Sugammadex or Neostigmine (based on institutional availability) and trachea would be extubated once patient meets criteria per attending anesthesiologist.
Endotracheal intubation would be facilitated by Succinylcholine (1-1.5mg/kg) or Remifentanil (1-2mcg kg-1) if Succinylcholine use is contraindicated. No non-depolarizing NMBA would be administered to the patients randomized to the NR group. Choice and technique of induction and maintenance of anesthesia, use of vasopressors, perioperative antibiotics, analgesics/adjunct regional techniques, prophylaxis for postoperative nausea and vomiting, fluid and blood component therapy would be left at the discretion of the anesthesia team. Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine) either as boluses or infusion would be recommended in case of sustained high peak airway pressures (\>35mm Hg), high intra-abdominal pressure, involuntary patient/diaphragmatic movement hindering surgical exposure and dissection. Choice and dose of adjunct/s to optimize operating conditions would be left to the discretion of the anesthesia team.

Eligibility Criteria

Sex:	All
Minimum Age:	18
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

Inclusion Criteria:

* At least 18 years of age
* Undergoing non-cardiac surgery under general anesthesia with an endotracheal tube
* those at higher risk of developing postoperative pulmonary complications (internally validated risk prediction score of \>=20)

Exclusion Criteria:

* Emergency surgery
* Ambulatory (outpatient) surgery
* Scheduled for elective postoperative ventilation
* Planned return to operating room within 7 days of index procedure
* Exposure to general anesthesia within 7 days prior to planned procedure
* Requirement mechanical ventilation at baseline (not including stable use of CPAP/BiPAP)
* Pregnant patients: as detected by patient self-reporting or diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC and MGH
* Allergy to either non-depolarizing muscle relaxants or sugammadex
* Clinician refusal
* Prisoner

Primary Outcomes

Composite of respiratory failure, suspected respiratory infection, aspiration pneumonia or pneumonitis, atelectasis, bronchospasm, reintubation and all cause in-hospital mortality

Secondary Outcomes

Vasopressor equivalent dose
Mean arterial pressure \<55mmHg
Was the operative condition optimal for the surgeon graded qualitatively using a numerical rating scale of 1-4. A score of 1 indicates excellent operating conditions whereas 4 indicates conditions unacceptable to the surgeon.

Other Outcomes

How often patients had to be readmitted to the hospital within 30 days of discharge from hospital following index procedure.
Time is takes for patients to be ready for discharge from PACU post operatively.
Cost of anesthetics used during surgical procedures in the study.
How often patients had either unanticipated ICU admissions or return to the operating room within 24 hours of the initial operation.
How much total time patients spent in the hospital after the operation.

More Details

NCT Number:	NCT03962725
Other IDs:	2019P000260
Study URL:	https://clinicaltrials.gov/study/NCT03962725

Last updated: Sep 29, 2023