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| ID | Type | Description | Link |
|---|---|---|---|
| 25-AKD-339 | Other Identifier | T.C. SAGLIK BAKANLIGI Türkiye Ilaç ve Tıbbi Cihaz Kurumu (Republic of Turkey Ministry of Health) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Placebo Comparator | After induction of anesthesia and prior to skin incision, normal saline labeled as the study drug will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine group | Other | Ketamine group: Single IV bolus of ketamine 1 mg/kg administered after induction of anesthesia and prior to skin incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MUHAMMET ESAT DEMIREL | Contact | 5426350983 | mesatdemirel24@gmail.com | |
| ERALP CEVİKKALP | Contact |
| Name | Affiliation | Role |
|---|---|---|
| MUHAMMET ESAT DEMIREL | Bursa City Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital, | Bursa | nilüfer | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28576285 | Background | 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. | |
| 25849690 |
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Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D035061 | Control Groups |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. |
|
|
| Two days starting from the day of surgery the day of enrollment |
| Time to first rescue analgesic request | Intravenous morphine 0.05 mg/kg will be used as rescue analgesia. | 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 | Delirium in the ICU will be assessed using the CAM-ICU and documented. | 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) | 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) | 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 | 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 | The period from the day of surgery (day of enrollment) until 6 mounth. |
| 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. | The period from the day of surgery (day of enrollment) until 6 mounth. |
| 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. |
| 26988335 | 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. |
| 25060512 | 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. |
| 31149930 | 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. |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |