Trial Outcomes & Findings for Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery (NCT NCT03643796)

Last Updated: 2023-09-18

Results Overview

Gross visible movement reported by the anesthesiologist or surgical team: bucking, chewing, or reaching to the endotracheal tube and induced by nociception, or head manipulation and positioning by the surgical or anesthesiology team or during a motor evoked potential stimulation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

duration of surgery

Results posted on

2023-09-18

Participant Flow

Recruitment was all done in the Preoperative area at the morning of the surgery

No wash outs or run-in has occurred

Participant milestones

Participant milestones
Measure	Remifentanil Group Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Overall Study STARTED	15	17
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remifentanil Group n=15 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=17 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=99 Participants	14 Participants n=107 Participants	27 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Age, Continuous	46 years STANDARD_DEVIATION 20 • n=99 Participants	52 years STANDARD_DEVIATION 19 • n=107 Participants	49 years STANDARD_DEVIATION 20 • n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants	14 Participants n=107 Participants	27 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	15 participants n=99 Participants	17 participants n=107 Participants	32 participants n=206 Participants

PRIMARY outcome

Timeframe: duration of surgery

Outcome measures

Outcome measures
Measure	Remifentanil Group n=15 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=17 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Incidence of Unacceptable Movement Under General Anesthesia	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 24 hours

Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia

Outcome measures

Outcome measures
Measure	Remifentanil Group n=15 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=17 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Hemodynamic Stability	4 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 24 hours

From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.

Outcome measures

Outcome measures
Measure	Remifentanil Group n=15 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=17 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Time to Extubation	12 minutes Standard Deviation 7	18 minutes Standard Deviation 7

SECONDARY outcome

Timeframe: 24 hours post-op

( Modified Quality of Recovery score, QoR-15) is a psychometric assessment of recovery from general anesthesia.Answers of 15 questions are given scores from 1 to 10 on a Likert scale. The score ranges from 0 to 150. The questionnaire is designed to assess the emotional state, physical comfort, psychological support, physical independence, and pain. A higher score indicates a better outcome

Outcome measures

Outcome measures
Measure	Remifentanil Group n=17 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=15 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Quality of Recovery	122 units on a scale Standard Deviation 7	127 units on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: 24 hours

all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.

Outcome measures

Outcome measures
Measure	Remifentanil Group n=15 Participants Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.	Ketamine and Dexmedetomidine Group n=17 Participants dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
Narcotic Consumption	12.7 Morphine Equivalents Standard Deviation 2.4	11.5 Morphine Equivalents Standard Deviation 2.7

Adverse Events

Ketamine and Dexmedetomidine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohamed Abdeldayem

University of Arkansas for Medical Sciences

Phone: 2244279747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place