Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

June 30, 2009

Study Completion Date

March 31, 2010

Conditions
HypotensionValve Surgery
Interventions
DRUG

Ephedrine

Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing either saline 0.9% solution \[group 1 (n=30)\], ephedrine 0.7 mg/mL \[group 2 (n=30)\], ephedrine 1 mg/mL \[group 3 (n=30)\] or ephedrine 1.5 mg/mL \[group 4 (n=30)\]or phenylephrine 15 mcg/mL \[group 5 (n=30)\]. All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo and the ephedrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.

DRUG

Placebo

Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing either saline 0.9% solution \[group 1 (n=30)\], ephedrine 0.7 mg/mL \[group 2 (n=30)\], ephedrine 1 mg/mL \[group 3 (n=30)\] or ephedrine 1.5 mg/mL \[group 4 (n=30)\]or phenylephrine 15 mcg/mL \[group 5 (n=30)\]. All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo and the ephedrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.

DRUG

Phenylephrine

Subjects were allocated randomly to five groups by drawing sequentially numbered sealed opaque envelopes containing a computer-generated randomization code. The subjects received intravenous injection of 0.1 mL/kg of a study solution containing 15 mcg/ml of phenylephrine \[group 5 (n=30)\] All study solutions were injected over 1 min at 1 min before induction of anesthesia. The placebo, the ephedrine, and the phenylephrine solutions were prepared in identical syringes labeled 'study drug' by the local pharmacy department before induction of anesthesia.

Trial Locations (2)

Unknown

Mansoura University Hospitals, Al Mansurah

King Fahd Hospital of the University, Dammam

All Listed Sponsors
collaborator

Mansoura University

OTHER

lead

King Faisal University

OTHER

NCT01006863 - Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study | Biotech Hunter | Biotech Hunter