Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery

NCT07490457 | Not Yet Recruiting

• 1 other identifier: 25-AKD-339
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Pain; Post Operative Pain, Acute; Ketamine; Pain; Cardiac Anaesthesia; Post Operative Pain, Chronic

Keywords

Postoperative chronic pain; ketamine; Open-heart surgery; Intraoperative ketamine

Outcome Measures

Primary Outcomes (2)

• Presence of postoperative chronic pain at 3 months

  Incidence of persistent postoperative pain at 3 months.

  From the day of surgery through 6 months postoperatively.

• Presence of postoperative chronic pain at 6 months

  Incidence of persistent postoperative pain at 6 months.

  From the day of surgery to 6 months postoperatively.

Secondary Outcomes (6)

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

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

• Time to first rescue analgesic request

  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.

• ICU delirium assessed by CAM-ICU

  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.

• Quality of Recovery-15 (QoR-15)

  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

• Brief Pain Inventory-Short Form

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

Study Arms (2)

Ketamine Group

EXPERIMENTAL

After induction of anesthesia and prior to skin incision, 1 mg/kg IV ketamine labeled as the study drug will be administered.

Other: Ketamine group

Control Group

PLACEBO COMPARATOR

After induction of anesthesia and prior to skin incision, normal saline labeled as the study drug will be administered.

Other: Control Group

Interventions

Ketamine group OTHER

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

Also known as: KETALAR, KETASOL, KETAMİN

Ketamine Group

Control Group OTHER

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

Also known as: normal saline

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• History of neuropathic pain
• Neurocognitive disorders such as psychosis or dementia
• Use of antidepressants or antipsychotics
• Body mass index (BMI) \> 40

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital,

Bursa, nilüfer, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28576285 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26988335 BACKGROUND

• 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.

  PMID: 25060512 BACKGROUND

• 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.

  PMID: 31149930 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative; Pain

Interventions

Ketamine; Control Groups; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• MUHAMMET ESAT DEMIREL

  Bursa City Hospital

  STUDY CHAIR

Central Study Contacts

MUHAMMET ESAT DEMIREL

CONTACT

5426350983; mesatdemirel24@gmail.com

ERALP CEVİKKALP

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 24, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)