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Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery

NCT07490457 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-24

No results posted yet for this study

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

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

Interventions

OTHER

Ketamine group

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

OTHER

Control Group

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

Sponsors & Collaborators

  • Bursa City Hospital

    lead OTHER_GOV

Principal Investigators

  • MUHAMMET ESAT DEMIREL · Bursa City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490457 on ClinicalTrials.gov