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

NCT ID: NCT05752110

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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

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Ketamine Minor Surgical Procedure Total Mood Score Woman

Keywords

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ketamine POMS questionnary acute Mood fractional curettage propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

0.09% Saline (0.05ml/kg) intravenously administered

Interventions

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Ketamine

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

Intervention Type DRUG

Saline

0.09% Saline (0.05ml/kg) intravenously administered

Intervention Type OTHER

Other Intervention Names

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subanesthetic dose of Ketamine Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sevim Baltali

Principal Investigator; M.D. Department of Anesthesiology, Istanbul Training and Research Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet TOPTAS, Ass.Prof.Dr

Role: STUDY_CHAIR

Istanbul Training and Research Hospital

Locations

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Istanbul Training and Research Hospital

Istanbul, Fatih, Turkey (Türkiye)

Site Status

IstanbulTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40739637 (View on PubMed)

Other Identifiers

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106/2022

Identifier Type: -

Identifier Source: org_study_id