Trial Outcomes & Findings for Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques (NCT NCT03996148)

NCT ID: NCT03996148

Last Updated: 2022-04-06

Results Overview

Time to first neurological exam after emergence from general anesthesia

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: up to 1 hour after emergence from general anesthesia.
• Results posted on: 2022-04-06

Participant Flow

Participant milestones

Measure	Remifentanil, Propofol, and Desflurane Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC	Remifentanil, Dexmedetomidine, and Desflurane Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC	Remifentanil and Desflurane Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Overall Study STARTED	7	7	7
Overall Study COMPLETED	7	6	7
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Remifentanil, Propofol, and Desflurane n=7 Participants Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC	Remifentanil, Dexmedetomidine, and Desflurane n=6 Participants Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC	Remifentanil and Desflurane n=7 Participants Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable	Total n=20 Participants Total of all reporting groups
Sex: Female, Male Male	6 Participants n=7 Participants	4 Participants n=6 Participants	6 Participants n=7 Participants	16 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	6 participants n=6 Participants	7 participants n=7 Participants	20 participants n=20 Participants
Age, Continuous	70 years STANDARD_DEVIATION 4 • n=7 Participants	73 years STANDARD_DEVIATION 12 • n=6 Participants	70 years STANDARD_DEVIATION 10 • n=7 Participants	71 years STANDARD_DEVIATION 10 • n=20 Participants
Sex: Female, Male Female	1 Participants n=7 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	4 Participants n=20 Participants
Preoperative Short Blessed Test	4 units on a scale n=7 Participants	0 units on a scale n=6 Participants	5 units on a scale n=7 Participants	4 units on a scale n=20 Participants
Confusion Assessment Method (3D CAM)	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: up to 1 hour after emergence from general anesthesia.

Time to first neurological exam after emergence from general anesthesia

Outcome measures

Measure	Remifentanil, Propofol, and Desflurane n=7 Participants Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC	Remifentanil, Dexmedetomidine, and Desflurane n=6 Participants Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC	Remifentanil and Desflurane n=7 Participants Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Time to First Neurological Exam	9 Minutes Standard Deviation 4	7 Minutes Standard Deviation 4	7 Minutes Standard Deviation 3

Adverse Events

Remifentanil, Propofol, and Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil, Dexmedetomidine, and Desflurane

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Remifentanil and Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Remifentanil, Propofol, and Desflurane n=7 participants at risk Study group A: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Propofol, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC	Remifentanil, Dexmedetomidine, and Desflurane n=7 participants at risk Study group B: no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil, Dexmedetomidine, and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC	Remifentanil and Desflurane n=7 participants at risk Study group C (control group): no midazolam given; maintenance drugs started immediately after induction and airway is secured. Remifentanil and Desflurane: Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
Nervous system disorders SAE	0.00% 0/7 • 30 days after enrollment	14.3% 1/7 • 30 days after enrollment	0.00% 0/7 • 30 days after enrollment

Other adverse events

Adverse event data not reported

Additional Information

Ludmil Mitrev

Cooper University Hospital

Phone: (800) 826-6737

Email: mitrev-ludmil@cooperhealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place