Effect of Intravenous Dexamethasone on The Duration of Hyperbaric Bupivacaine Spinal Anesthesia in Lower Abdominal Surgery-Quasi Experimental Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Time to Spinal Anesthesia regression
研究概览
简要总结
This study will evaluate whether intravenous dexamethasone affects the duration of spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible adult patients classified as ASA I or II will undergo routine preoperative assessment by an anesthetist. Before surgery, patients will receive either intravenous dexamethasone (8 mg diluted in 100 mL normal saline) or 100 mL normal saline alone. The medication will be administered through a peripheral intravenous cannula.
Spinal anesthesia will then be performed using a standard technique. A 25-gauge spinal needle will be used to administer 12-15 mg of 0.75% hyperbaric bupivacaine into the lower lumbar region while the patient is in the sitting position. After confirming the flow of cerebrospinal fluid, the patient will be positioned for surgery.
The level and effectiveness of anesthesia will be assessed using standard sensory and motor assessments. Surgery will begin after an adequate level of numbness and motor block has been achieved. The recovery of sensory and motor function will subsequently be assessed at regular 15-minute intervals by an anesthesia team member who was not involved in administering the spinal anesthesia, to minimize assessment bias.
The main outcome will be the time required for the sensory block to regress from its initial level to the lower thoracic region (T10-T12). Additional outcomes will include the total duration of sensory and motor block and postoperative pain, assessed using a visual pain scale four hours after surgery.
Patient information such as age, sex, diagnosis, type of surgery, duration of sensory and motor block, and postoperative pain score will be recorded and analyzed to determine whether intravenous dexamethasone prolongs the duration of spinal anesthesia.
详细描述
This study will evaluate the effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in patients undergoing lower abdominal surgery.
Eligible patients will be adults classified as American Society of Anesthesiologists (ASA) physical status I or II and meeting the predefined inclusion and exclusion criteria. All patients will undergo a preoperative assessment by a consultant anesthetist and will be deemed fit for anesthesia and surgery before enrollment.
After establishment of standard monitoring in the operating theatre, an 18-gauge peripheral intravenous cannula will be secured. Patients will receive either 8 mg of dexamethasone diluted in 100 mL of normal saline or 100 mL of normal saline alone, according to the study protocol. The administration will be performed in a manner intended to maintain blinding of the personnel responsible for subsequent assessment of block regression.
Following the intravenous intervention, spinal anesthesia will be performed using a 25-gauge spinal needle with the patient in the sitting position. A dose of 12-15 mg of 0.75% hyperbaric bupivacaine will be administered intrathecally at the L3-L4 or L4-L5 intervertebral space. Correct intrathecal placement will be confirmed by free flow of cerebrospinal fluid through the spinal needle. The patient will subsequently be positioned supine.
The sensory block will be assessed by testing the response to pinprick at the relevant dermatomes, while the degree of motor blockade will be assessed using the Modified Bromage Scale. Surgery will commence after an adequate sensory block extending to the T4 dermatome and a Modified Bromage score of 1 have been achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing lower abdominal surgeries and orthopaedic surgeries including pelvic and lower extremity surgeries
- •Patients classified as American Society of Anesthesiologists (ASA) physical status I or II
排除标准
- •Patients with a history of spinal surgery, spinal instrumentation, or previous failed spinal anaesthesia
- •Patients with pre-existing neurological disorders, peripheral neuropathy, or sensory/motor deficits
- •Patients with known hypersensitivity or allergy to local anaesthetic agents or dexamethasone
- •Patients with congenital spinal deformities or acquired spinal conditions such as advanced spondylosis or kyphoscoliosis that may interfere with neuraxial block
- •Patients with contraindications to spinal anaesthesia, including coagulopathy, local infection at the injection site, or raised intracranial pressure
- •Patients with diabetes mellitus, chronic steroid therapy, immunosuppression, or systemic infection (due to steroid use)
- •Pregnant patients or those undergoing emergency surgeries
研究组 & 干预措施
Control group
Will receive 100ml of normal saline
干预措施: Placebo (Drug)
Group Dexamethasone
8mg of Dexamethasone in 100ml Normal Saline will be administered
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Time to Spinal Anesthesia regression
时间窗: From administration of spinal anesthesia until sensory block regresses by two dermatomes, assessed for up to 6 hours after spinal anesthesia
Time in minutes from administration of spinal anesthesia until sensory block regresses by two dermatomes from the maximum sensory block level.
Time in minutes from administration of spinal anesthesia until the patient first requests rescue analgesia.
时间窗: From administration of spinal anesthesia until the patient's first request for rescue analgesia, assessed for up to 6 hours after spinal anesthesia.
次要结局
未报告次要终点
研究者
Dr. Tayyab Masood
Principal Investigator
Holy Family Hospital, Pakistan