Clinical Trials Directory

Trials / Completed

CompletedNCT05752110

Effects of Subanesthetic Dose of Ketamine Given on Postoperative Mood in Patients Undergoing Fractional Curettage

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Istanbul Training and Research Hospital · Other Government
Sex
Female
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Women admitted for fractional curettage between the ages of 18 and 75 were asked if they would like to participate in the study. Exclusion criteria included uncontrolled hypertension, pregnancy, history of psychologic disorders, use of brain-affecting medicines, substance abuse, seizure disorders, or ketamine allergy. After receiving informed consent, the patient would be given a POMS questionnaire. The participants were then assigned randomly to one of two groups. Group A will receive ketamine intravenously at a dose of 0.5 mg/kg as part of the induction process for general anesthesia. In addition to their anesthetic, Group B will get the same amount of saline instead of ketamine. Patients were treated by a different anesthetic professional (who is blinded to the group the patient is in). All other induction medicines were administered at the discretion of the anesthesiologist. Two hours after the surgery, participants were again administered the POMS questionnaire, questioned about their pain level, and their data sheet was updated accordingly. During the trial, the levels of sedation, systolic and diastolic blood pressures and heart rate were measured. In addition, any adverse events were documented.

Conditions

Interventions

TypeNameDescription
DRUGKetamine0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered
OTHERSaline0.09% Saline (0.05ml/kg) intravenously administered

Timeline

Start date
2022-04-01
Primary completion
2022-09-01
Completion
2022-09-01
First posted
2023-03-02
Last updated
2023-12-06

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05752110. Inclusion in this directory is not an endorsement.