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Cardiac AnaesthesiaNCT07490457

Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery

A study testing Ketamine group in people with Cardiac Anaesthesia and Chronic Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this interventional study is to determine whether a single intraoperative IV dose of ketamine can reduce postoperative chronic and acute pain and postoperative opioid requirements in adult patients undergoing open-heart surgery under general anesthesia. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ketamine group
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Apr 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA II-III,
  • Patients scheduled for elective on-pump open cardiac surgery via median sternotomy.

Who cannot join

  • Emergency surgery requirement
  • Need for reoperation
  • Requirement for postoperative re-intubation
  • History of opioid use
  • Preoperative diabetic neuropathy or autonomic dysfunction
  • Hepatic or renal dysfunction
Show all 10Show fewer
  • History of neuropathic pain
  • Neurocognitive disorders such as psychosis or dementia
  • Use of antidepressants or antipsychotics
  • Body mass index (BMI) > 40

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

MUHAMMET ESAT DEMIREL contact

5426350983

mesatdemirel24@gmail.com

ERALP CEVİKKALP contact

Turkey (Türkiye)1 site
  • Bursa City Hospital,

    Bursa, nilüfer

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Intraoperative Ketamine Administration on Postoperative Chronic Pain in Patients Undergoing Open Cardiac Surgery

The goal of this interventional study is to determine whether a single intraoperative IV dose of ketamine can reduce postoperative chronic and acute pain and postoperative opioid requirements in adult patients undergoing open-heart surgery under general anesthesia. The main questions it aims to answer are:

Primary outcome: Does a single-dose intraoperative IV ketamine reduce the presence and severity of pain at 3 and 6 months after surgery ? Secondary outcomes: Does it reduce acute postoperative pain scores, opioid consumption, and other recovery-related outcomes in the early postoperative period ? Researchers will compare a single-dose IV ketamine arm to a placebo arm to see if ketamine decreases chronic pain incidence at 3 and 6 months and improves acute pain/opioid-related outcomes.

Read more

Participants will:

Be randomized to receive either a single IV bolus of ketamine or placebo during surgery.

Undergo standard general anesthesia and open cardiac surgery per protocol. Have postoperative pain assessed using Numeric Rating Scale (NRS) at extubation, 0, 3, 6, 12, 24, and 48 hours.

Have opioid and additional analgesic use recorded, time to first rescue analgesic noted, and ICU/hospital length of stay tracked.

Be evaluated for ICU delirium (CAM-ICU) and complete Quality of Recovery-15, Brief Pain Inventory-Short Form, and Pain Self-Efficacy questionnaires.

Be followed up at 3 and 6 months for assessment of chronic postoperative pain.

Read the detailed description

The effect of intraoperative ketamine on postoperative chronic pain, acute pain, and postoperative opioid requirements will be evaluated in patients undergoing median sternotomy open-heart surgery under general anesthesia.

This study is a prospective, randomized, controlled, double-blind trial comparing intraoperative intravenous ketamine administered before the surgical incision with placebo in elective on-pump median sternotomy open cardiac surgery patients.

All patients will receive standard monitoring and catheterization. After anesthesia induction and before skin incision, patients will be assigned to the ketamine group or the control group. The ketamine group will receive 1 mg/kg intravenous ketamine; the control group will receive placebo normal saline.

In the postoperative period, all patients will receive cardiovascular management, ventilatory support, and extubation according to institutional ICU protocols. Per institutional protocol, postoperative analgesia will include IV paracetamol 1 g every 6 hours and tramadol infusion 300 mg/50 mL over 24 hours. For sedation and analgesia, a fentanyl infusion of 0.5-1.5 mcg/kg/hour will be titrated to maintain VAS < 5. Intravenous morphine 0.05 mg/kg will be used as rescue analgesia.

Ketamine group: 1 mg/kg IV ketamine after induction and before skin incision. Control group: Normal saline Study objective: To investigate the effect of a single intraoperative dose of ketamine on postoperative chronic pain, acute pain, and postoperative opioid requirements in patients undergoing open-heart surgery under general anesthesia.

Population: Patients undergoing on-pump open cardiac surgery via median sternotomy under general anesthesia.

Study design: Prospective, randomized, double-blind, observational cohort study.

Patients:

Age 18-80 years Total sample size: 100 patients Country: Turkey - indicate the planned number of volunteers to be enrolled from our country.

Preoperative Management:

Demographic data (age, weight, height, sex, body mass index), preoperative chronic diagnoses, smoking history, and preoperative medications will be recorded. Surgical type and indication will also be documented.

Intraoperative Period:

Hemodynamic and respiratory parameters (oxygen saturation [SpO2], heart rate [HR], and blood pressure [BP]) will be recorded at baseline before induction (T0), immediately before aortic cross-clamping (T1), and one hour after aortic cross-clamp removal (T2). Surgical type, operative duration, cardiopulmonary bypass (CPB) time, aortic cross-clamp time, and hourly urine output will also be recorded.

Postoperative Assessments:

Patients will be monitored with routine postoperative complete blood count and biochemical tests in the intensive care unit. Pain scores using the Numeric Rating Scale (NRS) will be assessed at extubation and at 0, 3, 6, 12, 24, and 48 hours post-extubation. Additional analgesic requirements within the first 24 hours, time to first rescue analgesic request, ICU length of stay, and total hospital length of stay will be recorded. Delirium in the ICU will be assessed using the CAM-ICU and documented. Prior to discharge, the Quality of Recovery-15 (QoR-15) questionnaire will be administered and scored. At postoperative months 3 and 6, patients will be contacted by telephone and chronic pain will be evaluated using the Brief Pain Inventory-Short Form; patients reporting pain will additionally be assessed with the Pain Self-Efficacy Questionnaire and the data recorded.

Being tested
Ketamine group, Control Group
Keywords
Postoperative chronic pain, ketamine, Open-heart surgery, Intraoperative ketamine
Medical subject headings
Chronic Pain, Pain, Postoperative, Pain

What participants receive

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

  • Ketamine groupOther

    Also called KETALAR, KETASOL, KETAMİN

    Ketamine group: Single IV bolus of ketamine 1 mg/kg administered after induction of anesthesia and prior to skin incision

  • Control GroupOther

    Also called normal saline

    Control group: Single IV bolus of normal saline (placebo) labeled as study drug administered after induction of anesthesia and prior to skin incision.

Study groups in NCT07490457
Study groupRoleWhat they receive
Ketamine GroupExperimentalAfter induction of anesthesia and prior to skin incision, 1 mg/kg IV ketamine labeled as the study drug will be administered.
Receives: Other: Ketamine group
Control GroupPlacebo comparatorAfter induction of anesthesia and prior to skin incision, normal saline labeled as the study drug will be administered.
Receives: Other: Control Group

What is being measured

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

  1. Presence of postoperative chronic pain at 3 months

    Incidence of persistent postoperative pain at 3 months.

    Measured: From the day of surgery through 6 months postoperatively.

  2. Presence of postoperative chronic pain at 6 months

    Incidence of persistent postoperative pain at 6 months.

    Measured: From the day of surgery to 6 months postoperatively.

Secondary outcomes (6)
  1. Pain scores (Numeric Rating Scale ) at extubation and at 0, 3, 6, 12, 24, and 48 hours post-extubation

    Pain scores (Numeric Rating Scale ) at extubation and at 0, 3, 6, 12, 24, and 48 hours post-extubation

    The Numeric Rating Scale (NRS) is the most commonly used subjective pain assessment tool in which patients express pain intensity by choosing a number between 0 and 10 (or 0-100). 0 represents "no pain" and 10 represents "unbearable/worst pain," providing a quick, simple measure. 0 = no pain; 1-3 = mild; 4-6 = moderate; 7-10 = severe.

    Measured: Two days starting from the day of surgery the day of enrollment

  2. Time to first rescue analgesic request

    Intravenous morphine 0.05 mg/kg will be used as rescue analgesia.

    Measured: When the day of surgery is considered Day 1, it will be applied from the time the patient is admitted to the postoperative ICU until discharge from the ICU, for a maximum of 2 weeks.

  3. ICU delirium assessed by CAM-ICU

    Delirium in the ICU will be assessed using the CAM-ICU and documented.

    Measured: When the day of surgery is considered Day 1, it will be applied daily from the time the patient is admitted to the postoperative ICU until discharge from the ICU, for a maximum of 2 weeks.

  4. Quality of Recovery-15 (QoR-15)

    Prior to discharge, the Quality of Recovery-15 (QoR-15) questionnaire will be administered and scored.

    The QoR-15 (Quality of Recovery-15) is a 15-item patient-reported questionnaire that measures postoperative recovery across five domains: physical comfort, emotional state, physical independence, psychological support, and pain. Each item is scored on an 11-point numeric scale (0-10). Scoring: Item range: 0 to 10. Total score range: 0 to 150 (sum of 15 item. Higher scores indicate better recovery (i.e., higher quality of recovery)

    Measured: When the day of surgery is considered Day 1, it will be applied on the day of hospital discharge, for a maximum of 4 weeks

  5. Brief Pain Inventory-Short Form

    At postoperative months 3 and 6, patients will be contacted by telephone and chronic pain will be evaluated using the Brief Pain Inventory-Short Form

    The Brief Pain Inventory-Short Form (BPI-SF) is a patient-reported tool that assesses pain severity and pain-related functional interference.

    Structure: 9 core items-4 pain severity items (worst, least, average, current) and 7 interference items (general activity, mood, walking ability, normal work, relations with others, sleep, enjoyment of life). Response scale: 0-10 numeric rating for each item (0 = no pain / no interference, 10 = pain as bad as you can imagine / complete interference). Higher scores indicate greater pain intensity and worse functional interference

    Measured: The period from the day of surgery (day of enrollment) until 6 mounth.

  6. Pain Self-Efficacy Questionnaire

    At postoperative months 3 and 6, patients will be contacted by telephone and chronic pain will be evaluated using the Brief Pain Inventory-Short Form; patients reporting pain will additionally be assessed with the Pain Self-Efficacy Questionnaire and the data recorded.

    The Pain Self-Efficacy Questionnaire (PSEQ) assesses the confidence of people with pain in performing activities while in pain. 10 items (PSEQ-10) asking how confident the respondent is that they can do various activities/behaviors despite pain. 7-point scale per item, 0 = not at all confident, 6 = completely confident. Item range: 0-6 Total score range: 0-60 (sum of 10 items). Higher scores indicate greater pain self-efficacy (better ability/confidence to function despite pain). Higher = better self-efficacy; no universally fixed clinical cutoffs, but scores <20 often indicate low self-efficacy and scores >40 relatively high self-efficacy in many studies.

    Measured: The period from the day of surgery (day of enrollment) until 6 mounth.

Timeline

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

  1. First posted24 Mar 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490457
Sponsor's protocol ID
25-AKD-339
Other IDs
25-AKD-339
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Publications

  • Avidan MS, Maybrier HR, Abdallah AB, Jacobsohn E, Vlisides PE, Pryor KO, Veselis RA, Grocott HP, Emmert DA, Rogers EM, Downey RJ, Yulico H, Noh GJ, Lee YH, Waszynski CM, Arya VK, Pagel PS, Hudetz JA, Muench MR, Fritz BA, Waberski W, Inouye SK, Mashour GA; PODCAST Research Group. Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial. Lancet. 2017 Jul 15;390(10091):267-275. doi: 10.1016/S0140-6736(17)31467-8. Epub 2017 May 30.

    PubMed 28576285
  • Mazzeffi M, Johnson K, Paciullo C. Ketamine in adult cardiac surgery and the cardiac surgery Intensive Care Unit: an evidence-based clinical review. Ann Card Anaesth. 2015 Apr-Jun;18(2):202-9. doi: 10.4103/0971-9784.154478.

    PubMed 25849690
  • Guimaraes-Pereira L, Farinha F, Azevedo L, Abelha F, Castro-Lopes J. Persistent Postoperative Pain after Cardiac Surgery: Incidence, Characterization, Associated Factors and its impact in Quality of Life. Eur J Pain. 2016 Oct;20(9):1433-42. doi: 10.1002/ejp.866. Epub 2016 Mar 14.

    PubMed 26988335
  • McNicol ED, Schumann R, Haroutounian S. A systematic review and meta-analysis of ketamine for the prevention of persistent post-surgical pain. Acta Anaesthesiol Scand. 2014 Nov;58(10):1199-213. doi: 10.1111/aas.12377. Epub 2014 Jul 25.

    PubMed 25060512
  • Anwar S, Cooper J, Rahman J, Sharma C, Langford R. Prolonged Perioperative Use of Pregabalin and Ketamine to Prevent Persistent Pain after Cardiac Surgery. Anesthesiology. 2019 Jul;131(1):119-131. doi: 10.1097/ALN.0000000000002751.

    PubMed 31149930

Questions about this trial

What is this clinical trial studying?

A study testing Ketamine group in people with Cardiac Anaesthesia and Chronic Pain, run by Bursa City Hospital at 1 site 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact MUHAMMET ESAT DEMIREL (5426350983, mesatdemirel24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of postoperative chronic pain at 3 months (time frame: From the day of surgery through 6 months postoperatively.). 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 NCT07490457, which also lists 5 linked publications.

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 24 Mar 2026.

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