Comparison of hemodynamic stability and analgesic efficacy of topical intranasal lidocaine versus levobupivacaine in patient undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary tumour surgeries: A prospective randomized double blind study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the hemodynamic changes between both groups and report adverse effects if any.
研究概览
简要总结
Type of Study – Hospital based prospective randomized double blind study.
Period of Study – 18 months from the day of approval.
Place of study – Dept.of NeuroAnaesthesiology, Mahatma Gandhi Medical College and Hospital, Jaipur
Procedure/Method:
Patients undergoing the study were randomly assigned to receive intranasal packing with either 15 mL of 1.5% lidocaine or 15 mL of 0.5% levobupivacaine, both combined with 60mg of ephedrine (2 mL). This randomization process was carried out through stratified block randomization, ensuring an equal distribution of study drugs. The allocation was conducted by a biostatistician who was independent of the study using the Statistical Analysis System software. The sequence of randomization was then communicated to the pharmacist responsible for packaging the drugs. These drugs were carefully packaged in amber colored bottles, which were labeled numerically in accordance with the randomization sequence.
To maintain blinding throughout the study, neither the patients nor the investigators were aware of the assigned treatment. The randomization code was securely kept confidential in the pharmacy department until it was disclosed at the conclusion of the study. Prior to the surgical procedure, the appropriate study drug vial was provided to the scrub nurse by the principal investigator. The scrub nurse then prepared the packing solution by mixing the study drug with 60 mg of ephedrine (2 mL) in a sterile manner. Subsequently, six standard-sized packing gauzes were thoroughly soaked in the prepared solution and carefully inserted into both nasal cavities immediately after the patient was intubated.
The intranasal gauze packs remained in place for a duration of 20 minutes, coinciding with the time taken for the patient to be prepped and draped for the surgical procedure. After this period, the packs were removed to facilitate the commencement of the operation. Throughout this entire process, strict adherence to blinding protocols was maintained to prevent any bias in the study outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 65 years.
- •Both male and female patients.
- •American Society of Anesthesiologists physical class 2 or
- •Scheduled for endoscopic binostril transnasal transsphenoidal (TNTS) surgery.
- •Diagnosis of sellar or suprasellar tumors.
排除标准
- •Refusal to provide informed consent.
- •Preoperative cerebrospinal fluid leak.
- •Known allergy to local anesthetic agents.
- •Preoperative cardiac arrhythmias.
- •History of seizure disorders.
结局指标
主要结局
To compare the hemodynamic changes between both groups and report adverse effects if any.
时间窗: 3 min,(Post tracheal intubation),At insertion of endoscope,3 min. later, At start of mucosal dissection,1 min/2min/3min/4min/5min,10 min,20 min,30 min,40 min,50 min,60 min,1hr 30 min,2 hr,2hr 30 min,3hr.,At tracheal extubation
次要结局
- To compare intraoperative bleeding in the surgical field between both groups.
- To compare the time to extubation of patients between both groups.(Time to be recorded from the time of stopping the inhalation agent till the removal of endotracheal tube)
研究者
Dr.Shameer imam
Mahatma gandhi medical college and hospital jaipur