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

Ketamine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752110
• Other study ID #: 106/2022
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketamine
• Woman

Intervention

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

Other:
• Saline
0.09% Saline (0.05ml/kg) intravenously administered

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul	Fatih
Turkey	IstanbulTRH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diplopia	Presence of absence of diplopia reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Secondary	Headache	Presence of absence of headache reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Secondary	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
Secondary	Nausea	Presence of absence of nausea reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Secondary	Vomiting	Presence of absence of vomiting reported in clinical records electronic database by nurse or physician within time frame	120 minutes after surgery
Secondary	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
Secondary	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