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

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.

Study Overview

• Status: Completed
• Conditions: Ketamine; Woman; Minor Surgical Procedure; Total Mood Score
• Intervention / Treatment: Drug: Ketamine; Other: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • IstanbulTRH
  • Fatih
    • Istanbul, Fatih, Turkey
      • Istanbul Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketamine; Received 0.5mg/kg IV single dose ketamine in addition to propofol and fentanyl anesthesia at induction period of anesthesia.	Drug: Ketamine; 0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered; Other Names: subanesthetic dose of Ketamine
Placebo Comparator: Control; Received 0.05ml/kg IV % 0.9 saline in addition to propofol and fentanyl anesthesia at induction period of anesthesia.	Other: Saline; 0.09% Saline (0.05ml/kg) intravenously administered; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale for pain assessment	Numeric rating scale score (NRS) is commonly used for measuring pain intensity. It is scored from 0-10; 0 means no pain and 10 is the worst pain imaginable. NRS assessed at the 120 minutes postoperatively	120 minutes after surgery
Systolic blood pressure	Measuring systolic blood pressure (mmHg) before surgery and 120 minutes after surgery and comparing values between and within group K and group C	immediately before surgery and 120 minutes after surgery
diastolic blood pressure	Measuring diastolic blood pressure (mmHg) before surgery and 120 minutes after surgery and comparing values within groups and comparing values between and within group K and group C	immediately before surgery and 120 minutes after surgery
heart rate	Measuring number of heart beats per minute before surgery and 120 minutes after surgery and comparing values within groups and comparing values between and within group K and group C	immediately before surgery and 120 minutes after surgery
The Michigan Sedation Score assessment	Comparing depth of sedations of two groups using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation.	immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery
Diplopia	Presence of absence of diplopia reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Headache	Presence of absence of headache reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Psychedelic phenomena	Presence of absence of psychedelic phenomena reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Nausea	Presence of absence of nausea reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Vomiting	Presence of absence of vomiting reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Patient satisfaction	Evaluation of patient satisfaction 120 minutes after surgery. Satisfaction is rated on a scale of 1 to 4 (1 perfect, 2 good, 3 moderate, and 4 bad).	120 minutes after surgery
Physician satisfaction	Evaluation of physician satisfaction 120 minutes after surgery. Satisfaction is rated on a scale of 1 to 4 (1 perfect, 2 good, 3 moderate, and 4 bad).	120 minutes after surgery

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital
• Investigators: Study Chair: Mehmet TOPTAS, Ass.Prof.Dr, Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ketamine; propofol; POMS questionnary; acute Mood; fractional curettage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 106/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No