Effects of Subanesthetic Dose of Ketamine Given on Postoperative Mood in Patients Undergoing Fractional Curettage
This randomized controlled trial (n=140) investigated the impact of a single subanesthetic dose of ketamine (35mg/70kg) administered intravenously during the induction of propofol/fentanyl anesthesia on acute mood states in women undergoing fractional curettage.
Detailed Description
Randomised, triple-masked, parallel-group trial (n=140) comparing a single IV 0.5 mg/kg ketamine dose given at induction versus 0.9% saline placebo in women undergoing fractional curettage; primary outcome acute mood (POMS) before discharge.
Secondary measures include pain, sedation, blood pressure and heart rate, and adverse events; key exclusions were pregnancy, uncontrolled hypertension, seizure disorders, substance abuse and major medical disease.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
Ketamine
experimentalSingle IV 0.5 mg/kg ketamine at induction with propofol/fentanyl
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
Given at induction with propofol/fentanyl
Saline placebo
inactive0.09% saline 0.05 ml/kg IV at induction with propofol/fentanyl
Interventions
- Placebo0.05 ml/kgvia IV• single dose• 1 doses total
0.05 ml/kg 0.9% saline
Participants
Inclusion Criteria
- Inclusion Criteria:
- Consecutive patients (>18 years) undergoing fractional curettage
Exclusion Criteria
- Exclusion Criteria:
- American Society of Anesthesiologists' physical status ≥ 3
- History of psychological disorders
- Use of drugs affecting the central nervous system
- Substance abuse
- Chronic pain
- Pregnancy
- Seizure disorders
- Cardiovascular, hepatic or renal disease
Study Details
- StatusCompleted
- PhasePhase IV
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment140 participants
- TimelineStart: 2022-04-01End: 2022-09-01
- Compounds
- Topic