Clinical trial

Does Subanesthetic Dose of Ketamine Given at Induction of Anesthesia Improve Postoperative Mood In Women Undergoing Fractional Curettage? A Randomized Controlled Trial

Name
106/2022
Description
When given intravenously in doses below 1.2mg/kg, ketamine has been shown to work as an antidepressant. Ketamine is a common induction drug used during general anesthesia. It is known to reduce postoperative pain in this instance. Limited studies have evaluated the effect of a single subanesthetic dosage of ketamine administered as an adjunct to general anesthesia on acute mood states in patients undergoing minor surgery. The aim of this randomized controlled study was to examine if a single intravenous administration of 0.5 mg/kg ketamine given at the induction of propofol/fentanyl anesthesia has an effect on acute mood states before the discharge of women undergoing fractional curettage.
Trial arms
Trial start
2022-04-01
Estimated PCD
2022-09-01
Trial end
2022-09-01
Status
Completed
Phase
Early phase I
Treatment
Ketamine
0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered
Arms:
Ketamine
Other names:
subanesthetic dose of Ketamine
Saline
0.09% Saline (0.05ml/kg) intravenously administered
Arms:
Control
Other names:
Placebo
Size
140
Primary endpoint
Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire.
Total Mood Score measured 120 minutes after surgery
Impact of clinical variables on total mood scores using Profile of Mood States (POMS)
120 minutes after surgery
Eligibility criteria
Inclusion Criteria: * consecutive patients (\>18 years) undergoing fractional curettage Exclusion Criteria: * American Society of Anesthesiologists' physical status ≥ 3 * History of psychological disorders * Use of drugs affect central nervous system * Substance abuse * Chronic pain * Pregnancy * Seizure disorders * Cardiovascular, hepatic or renal disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2023-12-06

1 organization

1 drug

4 indications

Indication
Ketamine
Indication
Female