Trial Outcomes & Findings for Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy (NCT NCT02430389)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Ten minute window after head fixation

Results posted on

2015-06-30

Participant Flow

Northwestern Memorial Hospital Ambulatory Surgery Unit or equivalent location where preoperative anesthesia evaluation occurring.

Participant milestones

Participant milestones
Measure	Remifentanil Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	Normal Saline Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Placebo
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remifentanil n=10 Participants Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	Normal Saline n=10 Participants Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Placebo	Total n=20 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 12.2 • n=5 Participants	51.7 years STANDARD_DEVIATION 4.8 • n=7 Participants	56.5 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Ten minute window after head fixation

Outcome measures

Outcome measures
Measure	Remifentanil n=10 Participants Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	Normal Saline n=10 Participants Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Placebo
Mean Arterial Blood Pressure After Head Fixation	76 mm Hg Standard Deviation 8	83 mm Hg Standard Deviation 12

SECONDARY outcome

Timeframe: 10 minute window after head fixation

Outcome measures

Outcome measures
Measure	Remifentanil n=10 Participants Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.	Normal Saline n=10 Participants Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Placebo
Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations	5 participants	8 participants

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Remifentanil

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal Saline n=10 participants at risk Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Placebo	Remifentanil n=10 participants at risk Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning.
Cardiac disorders hemodynamic perturbation	80.0% 8/10 • Number of events 31 • 10 minutes post Mayfield head-pinning. In addition, patients were given contact information for study director if they had concerns of an adverse event or other concerns upon conclusion of study/recovery from anesthesia. Assessment of adverse reactions via chart review with need for rescue drug therapy.	50.0% 5/10 • Number of events 11 • 10 minutes post Mayfield head-pinning. In addition, patients were given contact information for study director if they had concerns of an adverse event or other concerns upon conclusion of study/recovery from anesthesia. Assessment of adverse reactions via chart review with need for rescue drug therapy.

Additional Information

Laura B. Hemmer, M.D.

Northwester University

Phone: 312-695-0061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place