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AzTrials

KetaminePhase 4NCT05752110

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

A Phase 4 study testing Ketamine and Saline in people with Ketamine and Minor Surgical Procedure, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Ketamine and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Apr 2022to 1 Sep 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • consecutive patients (>18 years) undergoing fractional curettage

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Istanbul Training and Research Hospital

    Istanbul, Fatih

  • IstanbulTRH

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Ketamine, Saline
Keywords
ketamine, POMS questionnary, acute Mood, fractional curettage, propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called subanesthetic dose of Ketamine

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

  • SalineOther

    Also called Placebo

    0.09% Saline (0.05ml/kg) intravenously administered

Study groups in NCT05752110
Study groupRoleWhat they receive
KetamineActive comparatorReceived 0.5mg/kg IV single dose ketamine in addition to propofol and fentanyl anesthesia at induction period of anesthesia.
Receives: Drug: Ketamine
ControlPlacebo comparatorReceived 0.05ml/kg IV % 0.9 saline in addition to propofol and fentanyl anesthesia at induction period of anesthesia.
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Total Mood Score measured 120 minutes after surgery

  2. 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.

    Measured: 120 minutes after surgery

Secondary outcomes (12)

  1. 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

    Measured: 120 minutes after surgery

  2. 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

    Measured: immediately before surgery and 120 minutes after surgery

  3. 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

    Measured: immediately before surgery and 120 minutes after surgery

  4. 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

    Measured: immediately before surgery and 120 minutes after surgery

  5. 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.

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

  6. Diplopia

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

    Measured: 120 minutes after surgery

  7. Headache

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

    Measured: 120 minutes after surgery

  8. Psychedelic phenomena

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

    Measured: 120 minutes after surgery

  9. Nausea

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

    Measured: 120 minutes after surgery

  10. Vomiting

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

    Measured: 120 minutes after surgery

  11. 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).

    Measured: 120 minutes after surgery

  12. 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).

    Measured: 120 minutes after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start1 Apr 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752110
Sponsor's protocol ID
106/2022
Status last verified
Nov 2023
First submitted
10 Feb 2023
Last updated
6 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40739637

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine and Saline in people with Ketamine and Minor Surgical Procedure, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05752110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

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