Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering; a Double Blinded, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The incidence of shivering.
研究概览
简要总结
This study aims to investigate the efficacy of oral ondansetron film strips on the incidence of post-spinal shivering in patients undergoing surgeries using spinal anesthesia at Kasr Alainy hospitals, Cairo University.
This prospective, double-blinded, randomized controlled study will be conducted on 50 patients aged from 18 to 65 years of both sexes with ASA I, II who are scheduled for elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries. Patients will be divided into two equal groups: Group (O) will receive oral ondansetron in the form of an oral soluble film 4 mg strip immediately before insertion of IV cannula and group (C) will receive a placebo in the form of an oral peppermint strip immediately before insertion of the IV cannula.
详细描述
In the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group O will receive oral ondansetron in the form of an oral soluble film 4 mg strip (Ondalenz, 4 mg orodispersible films of Nerhadou International Co.) and patients in group C will receive a placebo in the form of an oral peppermint strip (Listerine Cool Mint Pocketpakas).
Following the insertion of a cannula; IV midazolam at a dose of 0.05 mg/kg will be administered intravenously. Then the patient will be transferred immediately to the operating theatre.
On entering the operating room; all patients will be connected to standard ASA monitoring which included electrocardiography (ECG), non-invasive arterial blood pressure (NIBP) including systolic, diastolic, mean arterial blood pressure (MAP) and Oxygen saturation using pulse oximetry.
With the patient sitting on the operating table, the L3-L4 interspace will be identified by identification of Tuffier's line. Under complete aseptic conditions, a dural puncture will be achieved by a 22G pencil-point spinal needle that will be introduced in a paramedian (lateral) approach through the L3-4 intervertebral space. After CSF aspiration and confirmation of correct intrathecal space, 3.5 mL of Sunny Pivacaine 0.5% (hyperbaric bupivacaine 20mg/4mL amp of Sunny pharmaceutical group) plus 25 μg of fentanyl-Hameln (of Sunny pharmaceutical group) will be injected over one minute.
The sensory block will be assessed by a pinprick test and the motor block will be assessed using a modified Bromage scale (0 = no motor block; 1= hip is blocked; 2= hip and knee are blocked; 3= hip, knee, and ankle are blocked). Peak sensory level will be confirmed and if a sensory level < T8 the patient will be excluded. If general anesthesia is needed for any reason, the patient will also be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II.
- •Patients underwent elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries.
排除标准
- •Patient refusal.
- •Morbid obese patients or those who were not candidates for spinal anesthesia.
- •Pregnant females.
- •Patients with comorbidities such as severe cardiopulmonary, severe hepatic or renal diseases, thyroid disorders, and convulsions.
- •Uncooperative patients and patients with psychological disorders.
- •Patients on regular ondansetron or other antiemetics.
- •Patients taking selective serotonin reuptake inhibitors.
- •Patients with allergy to 5-HT3 receptor antagonist drugs.
- •Patients receiving saddle spinal block.
- •In surgeries less than 1 h or longer than 3 hours duration.
研究组 & 干预措施
Group O
Patients will receive oral ondansetron in the form of an oral soluble film 4 mg strip.
干预措施: Oral ondansetron strips (Drug)
Group C
Patients will receive a placebo in the form of an oral peppermint strip
干预措施: Placebo (oral peppermint strip) (Other)
结局指标
主要结局
The incidence of shivering.
时间窗: starting from 15 minutes after lumber puncture until 180 minutes following it and postoperative.
It is defined by the highest shivering score ≥ 3 at any time starting from 15 min after lumber puncture until 180 min following it.
次要结局
- The onset time of significant shivering(started from 15 minutes after lumbar injection until 180 minutes following lumbar injection and postoperative)
- Correlation between the incidence of shivering score ≥ 3 and hypothermia.(started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively)
- Incidence of hypothermia(started from 15 minutes after lumbar injection until 180 minutes after lumbar injection and postoperative.)
- The shivering score(will be assessed at 15 minutes intervals during the operation and in the recovery room started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperative.)
- Incidence of patients given pethidine(started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperativde.)
- The incidence of adverse effects(started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively)
- Correlation between the incidences of postoperative nausea, vomiting, and shivering(started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively)
研究者
Hany Mohammed El-Hadi Shoukat Mohammed
Assistant Professor
Cairo University