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.
ASA II-III,
Patients scheduled for elective on-pump open cardiac surgery via median sternotomy.
Emergency surgery requirement
Need for reoperation
Requirement for postoperative re-intubation
History of opioid use
Parallel
Ketamine group
Other interventionKetamine group: Single IV bolus of ketamine 1 mg/kg administered after induction of anesthesia and prior to skin incision
Control Group
Other interventionControl group: Single IV bolus of normal saline (placebo) labeled as study drug administered after induction of anesthesia and prior to skin incision.
Presence of postoperative chronic pain at 3 months
Incidence of persistent postoperative pain at 3 months.
Presence of postoperative chronic pain at 6 months
Incidence of persistent postoperative pain at 6 months.
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.
Time to first rescue analgesic request
Intravenous morphine 0.05 mg/kg will be used as rescue analgesia.
ICU delirium assessed by CAM-ICU
Delirium in the ICU will be assessed using the CAM-ICU and documented.
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)
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Bursa City Hospital
Lead sponsor
Bursa Sehir Hastanesi
Sponsor institution
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