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

NCT05752110 | Completed Phase 4

• 1 other identifier: 106/2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ketamine; Minor Surgical Procedure; Total Mood Score; Woman

Keywords

ketamine; POMS questionnary; acute Mood; fractional curettage; propofol

Outcome Measures

Primary Outcomes (2)

• Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire.

  The Turkish version of Profile of Mood States (POMS) is an validated instrument that measures mood using a 58-item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "very strong". Higher score indicates worse mood.As a global measure of affective state, a total mood score (TMS) is calculated by combining the negative mood subscore (NMS) totals (fatigue-inertia, anger-hostility, confusion-bewilderment, depression-dejection, tension-anxiety,) and subtracting the positive mood subscore (PMS) (vigor-activity). The minimum value of TMS is -24, the maximum value is+177.

  Total Mood Score measured 120 minutes after surgery

• Impact of clinical variables on total mood scores using Profile of Mood States (POMS)

  We perform multiple linear regression analyses to examine the independent predictors of changes in postoperative TMS in the entire study group, patients in group-K and group-C, separately. Postoperative TMS is the dependent variable; menopausal status, parity, educational level, body mass index (BMI) and preoperative TMS are independent variables.

  120 minutes after surgery

Secondary Outcomes (12)

• Numeric rating scale for pain assessment

  120 minutes after surgery

• Systolic blood pressure

  immediately before surgery and 120 minutes after surgery

• diastolic blood pressure

  immediately before surgery and 120 minutes after surgery

• heart rate

  immediately before surgery and 120 minutes after surgery

• The Michigan Sedation Score assessment

  immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Received 0.5mg/kg IV single dose ketamine in addition to propofol and fentanyl anesthesia at induction period of anesthesia.

Drug: Ketamine

Control

PLACEBO COMPARATOR

Received 0.05ml/kg IV % 0.9 saline in addition to propofol and fentanyl anesthesia at induction period of anesthesia.

Other: Saline

Interventions

Ketamine DRUG

0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered

Also known as: subanesthetic dose of Ketamine

Ketamine

Saline OTHER

0.09% Saline (0.05ml/kg) intravenously administered

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients (\>18 years) undergoing fractional curettage

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (2)

Istanbul Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Location

IstanbulTRH

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Baltali S, Ciftci E, Baltali M, Haliloglu M, Ercan A, Tunay A, Celik Z, Bozay B, Toptas M. Ketamine's impact on mood after day-case surgery and its relation to obesity: a randomised controlled trial in women undergoing fractional curettage. BMC Womens Health. 2025 Jul 30;25(1):380. doi: 10.1186/s12905-025-03920-y.

  PMID: 40739637 DERIVED

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mehmet TOPTAS, Ass.Prof.Dr

  Istanbul Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; M.D. Department of Anesthesiology, Istanbul Training and Research Hospital

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 2, 2023
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)