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NCT Number: NCT05752110

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

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.

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Key information

Conditions

Ketamine Minor Surgical Procedure Total Mood Score Woman

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul Training and Research Hospital, Istanbul, Fatih, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Other names: subanesthetic dose of Ketamine

Saline

Other

0.09% Saline (0.05ml/kg) intravenously administered

Other names: Placebo

Primary outcomes

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

    Time frame: Total Mood Score measured 120 minutes after surgery

    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.

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

    Time frame: 120 minutes after surgery

    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.

Secondary outcomes

  1. Numeric rating scale for pain assessment

    Time frame: 120 minutes after surgery

    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

  2. Systolic blood pressure

    Time frame: immediately before surgery and 120 minutes after surgery

    Measuring systolic blood pressure (mmHg) before surgery and 120 minutes after surgery and comparing values between and within group K and group C

  3. diastolic blood pressure

    Time frame: immediately before surgery and 120 minutes after surgery

    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

  4. heart rate

    Time frame: immediately before surgery and 120 minutes after surgery

    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

  5. The Michigan Sedation Score assessment

    Time frame: immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery

    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.

  6. Diplopia

    Time frame: 120 minutes after surgery

    Presence of absence of diplopia reported in clinical records electronic database by nurse or physician within time frame

  7. Headache

    Time frame: 120 minutes after surgery

    Presence of absence of headache reported in clinical records electronic database by nurse or physician within time frame

  8. Psychedelic phenomena

    Time frame: 120 minutes after surgery

    Presence of absence of psychedelic phenomena reported in clinical records electronic database by nurse or physician within time frame

  9. Nausea

    Time frame: 120 minutes after surgery

    Presence of absence of nausea reported in clinical records electronic database by nurse or physician within time frame

  10. Vomiting

    Time frame: 120 minutes after surgery

    Presence of absence of vomiting reported in clinical records electronic database by nurse or physician within time frame

  11. Patient satisfaction

    Time frame: 120 minutes after surgery

    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).

  12. Physician satisfaction

    Time frame: 120 minutes after surgery

    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).

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2023
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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