Efficacy of Ketamine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block in Adults Undergoing Supratentorial Brain Tumor Excision Surgeries for Hemodynamics and Pain Control, Double-blinded Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Analgesic efficacy of dexmedetomidine versus ketamine as adjuvants in scalp blocks
研究概览
简要总结
Supratentorial brain tumor surgeries are associated with significant nociceptive stimulation and postoperative pain, which may adversely affect patient outcomes. Scalp block has emerged as an effective regional anesthetic technique to improve analgesia and reduce opioid consumption.
Objective: To compare efficacy of ketamine versus dexmedetomidine as adjuvants to bupivacaine in scalp blocks for supratentorial brain tumor surgeries, focusing on analgesia, opioid consumption, and hemodynamic stability.
Methods:
This randomized double-blinded controlled trial included 80 patients undergoing supratentorial tumor excision, allocated equally into two groups: Group K received bupivacaine with ketamine (2 mg/kg), and Group D received bupivacaine with dexmedetomidine (1 µg/kg). Intraoperative hemodynamics, fentanyl consumption, postoperative pain scores (NRS), analgesic requirements, and complications were assessed.
详细描述
The study was designed as a prospective, double-blind, randomized controlled clinical trial to evaluate efficacy of Ketamine versus Dexmedetomidine as an adjuvant to Bupivacaine in Scalp Block in Adults undergoing Supratentorial Brain Tumor Excision Surgeries for Hemodynamic and Pain Control.
The study was carried out in neurosurgery operating rooms at Cairo University Hospital, Faculty of Medicine, Cairo University.
The study was approved by the Ethics Committee of Faculty of Medicine, Cairo University, MS-483-2025 Egypt. The trial was preregistered on clinicaltrials.gov, NCT06168903.Written informed consent was obtained from all patients. The Consolidated Standards of Reporting Trials (CONSORT) guidelines were adhered Informed written consent was obtained from each patient. There are adequate provisions to maintain participants' privacy and confidentiality of the data.
Randomization will be performed using computer-generated numbers. Allocation concealment will be maintained using serially numbered, opaque, and sealed envelopes. Investigators will remain blind to the sequence, with group assignments contained in envelopes marked only with case numbers. Before each case, a study nurse or assistant will open the corresponding numbered envelope to reveal the patient's group assignment.
- Dexmedetomidine (D):): Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 1 µg/kg of dexmedetomidine, with the remainder filled with saline.
- Ketamine (K): Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 2 mg/kg of ketamine, with the rest filled with saline. The syringes will be prepared by an anesthesia technician and handed blindly to the anesthetist to administer the block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 20 to 60 years, both sexes, American Society of Anesthesiologists (ASA) physical status II-III, Supratentorial tumor excision, Supine Position.
- •and operation time: less than 6 hours.
排除标准
- •Patient refusal, disturbed consciousness level (Glasgow Coma Scale [GCS] < 15). Patients who required reintubation during the study period, those not extubated. immediately after surgery, or those who awoke with neurological deficits impairing. pain assessments were excluded from the final analysis, history of psychotic disorders or previous surgeries, Poor cognitive function.
- •Postictal state or uncontrolled/recurrent seizures, known allergy to dexmedetomidine or ketamine, difficult intubation (Mallampati score > III) or multiple intubation attempts, operation duration > 6 hours, renal dysfunction (creatinine > 1.2 mg/dL, BUN > 20 mg/dL), heart block and patients with chronic headache disorders or those receiving chronic analgesic therapy (for >3 months) were excluded.
研究组 & 干预措施
Dexmedetomidine (D)
Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 1 µg/kg of dexmedetomidine, with the remainder filled with saline.
干预措施: Scalp Block with Bupivacaine (Drug)
Ketamine (K):
Patients will receive a scalp block with a 20 ml syringe containing 1 mg/kg of 0.5% bupivacaine and 2 mg/kg of ketamine, with the rest filled with saline. The syringes will be prepared by an anesthesia technician and handed blindly to the anesthetist to administer the block.
干预措施: Scalp Block with Bupivacaine (Drug)
结局指标
主要结局
Analgesic efficacy of dexmedetomidine versus ketamine as adjuvants in scalp blocks
时间窗: 6 hours
Compare analgesic efficacy of dexmedetomidine versus ketamine as adjuvants in scalp blocks for supratentorial tumor resection by measuring total intraoperative fentanyl consumption (in µg).
次要结局
- Compare the time duration after extubating to request the first analgesia.(24 hours)
- Total analgesic consumption.(24 hours)
- NRS pain score(24 hours)
- Nausea and vomiting(24 hours)
- Side effects(24 hours)
研究者
Nagy Malak , MD
Principal investigator
Cairo University