Intraoperative Ketamine for Chronic Postoperative Pain After Open-Heart Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine group, Control Group.
- Who it may be relevant to
- Registry conditions: Cardiac Anaesthesia, Chronic Pain, Post Operative Pain, Chronic, Post Operative Pain, Acute. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Intraoperative Ketamine Administration on Postoperative Chronic Pain in Patients Undergoing Open Cardiac Surgery
Overview
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.
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.
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.
Primary outcome measures
- Presence of postoperative chronic pain at 3 months [Time frame: From the day of surgery through 6 months postoperatively.]
- Presence of postoperative chronic pain at 6 months [Time frame: From the day of surgery to 6 months postoperatively.]
Secondary outcome measures (6)
- Pain scores (Numeric Rating Scale ) at extubation and at 0, 3, 6, 12, 24, and 48 hours post-extubation [Time frame: Two days starting from the day of surgery the day of enrollment]
- Time to first rescue analgesic request [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: The period from the day of surgery (day of enrollment) until 6 mounth.]
- Pain Self-Efficacy Questionnaire [Time frame: The period from the day of surgery (day of enrollment) until 6 mounth.]
Eligibility criteria
Inclusion criteria
- ASA II-III,
- Patients scheduled for elective on-pump open cardiac surgery via median sternotomy.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Bursa City Hospital, — Bursa
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 interna PMID 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. PMID 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. PMID 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. PMID 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. PMID 31149930
Identifiers
NCT: NCT07490457 · 25-AKD-339 · 25-AKD-339