Effect of Intravenous Dexmedetomidine on Patient Discomfort in Laparoscopic Cholecystectomy Under Spinal Anesthesia. A Randomized Control Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraopertive shoulder pain
研究概览
简要总结
Laparoscopic cholecystectomy (LC) has been routinely performed under general anesthesia despite the several disadvantages of general anesthesia compared to regional anesthesia.
There are multiple reports that have been published regarding the feasibility of spinal anesthesia for LC associated with many problems such as referred shoulder pain secondary to intra-abdominal pneumoperitoneum; patient anxiety, pain, and discomfort; and inadequate sedation.The aim of our study is to prospectively observe the feasibility of using intravenous dexmedetomidine to abolish patient discomfort and shoulder pain, thus making the patient more comfortable without causing excessive sedation and respiratory depression.
详细描述
This is a prospective, randomized double blinded control study which will be conducted in department of anesthesia and surgical Intensive care unit at Theodor Bilharz Research Institute after approval by research ethics committee and patient informed consent. 40 patients will be enrolled in the study and divided into two groups 20 patients each ; either (Dexa group (D) or Control group (C).
Anesthesia Technique:
A preoperative assessment, including a history, physical examination, review of laboratory data, and assignment of ASA classification will be performed on all patients prior to the procedure. Anesthesia and procedural consent will be obtained.
After premedication with i.v. midazolam 2 mg , patients will be transferred to the operating theatre. Ringer's solution 500 ml will be given over 15 min, and patients will be premedicated with intravenous ondensetron 4 mg and intravenous atropine 0.2 mg.
IN DEXA GROUP:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded randomized control study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing elective laparoscopic Cholecystectomy with estimated pneumoperitoneum time of 60 to 90 min.
排除标准
- •Pregnancy.
- •Lactating women.
- •Any contraindication to spinal anesthesia e.g. Bleeding diathesis, infection at the puncture site, patient on anticoagulants or preexisting neurological deficits in lower extremities.
- •Patients on α2-adrenergic receptors antagonists, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
- •Patients known allergic to bupivacaine or dexmedetomidine
研究组 & 干预措施
Dexa group
Spinal anaesthesia will be performed through the L3-4 interspace in the sitting position. After dural puncture with a 25 G Quincke needle, 3.5 ml of hyperbaric bupivacaine 0.5% solution with fentanyl 20 μg will be injected intrathecally. Than manintance dose of dexmedetomidine will be titrated from (0.2- 0.6 mcg /kg/ min) according to the patient discomfort.
After turning the patient supine, level of sensory block will be assessed by the pinprick test using a 24-gauge hypodermic needle, while the motor block level will be assessed by the modified Bromage scale. Insufflation of gas will be done at the rate of 1.5 liters/min and the maximum abdominal pressure will be kept at 12 mmHg. Supplementary oxygen at 4 liters/min will be given with face mask.
干预措施: Dexmedetomidine (Drug)
Control group
Normal Saline as a placebo will be infused over a period of ten minutes then spinal anaesthesia will be performed through the L3-4 interspace in the sitting position. After dural puncture with a 25 G Quincke needle, 3.5 ml of hyperbaric bupivacaine 0.5% solution with fentanyl 20 μg will be injected intrathecally. Then the placebo will be titrated according to patient discomfort.
After turning the patient supine, level of sensory block will be assessed by the pinprick test using a 24-gauge hypodermic needle, while the motor block level will be assessed by the modified Bromage scale.Insufflation of gas will be done at the rate of 1.5 liters/min and the maximum abdominal pressure will be kept at 12 mmHg. Supplementary oxygen at 4 liters/min will be given with face mask.
干预措施: normal saline (Drug)
结局指标
主要结局
Intraopertive shoulder pain
时间窗: 60-90 minutes
The severity of pain will be graded as nil, mild, moderate and severe.
次要结局
- Number of intraoperative hypoxic episodes(60-90 minutes.)
研究者
Moshira sayed mohamed
Anesthesia and Intensive care clinical researcher
Theodor Bilharz Research Institute