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临床试验/CTRI/2025/11/097947
CTRI/2025/11/097947尚未招募4 期

Comparison of Hemodynamic and Intubation Responses to Propofol Induction using Schneider model TCI Versus Bolus Technique

Manipal Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年12月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
140
试验地点
1

研究概览

简要总结

This is study is a prospective, randomized, parallel group, single-center trial comparing the hemodynamic and intubation responses to propofol induction using Schneider model Target controlled infusion (TCI) and propofol IV. Adult patients between age of 18 to 60years undergoing elective surgery under general anesthesia will be randomly allocated to one of the two induction techniques using computer generated randomization. Hemodynamic parameters like Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Mean-arterial pressure (MAP) will be measured 1 minute before induction to 10 minutes after induction (or before surgical incision whichever is earlier).A total sample size of 140 participants (70 in each group) will be enrolled. The primary outcome is to evaluate the incidence of postinduction hypotension with TCI and manual bolus induction with propofol and secondary outcome is to compare the hemodynamic changes (heart rate and blood pressure) during laryngoscopy and tracheal intubation between TCI and manual bolus induction with propofol. The expected study duration is 10 months from the date of first patient enrolment.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA1 AND ASA2 2)Patients with BMI less than 35 3)Patients undergoing general anesthesia with endotracheal tube placement.

排除标准

  • Patient refusal to participate in study 2)Patient allergic to propofol 3)ASA III or IV 4)Patients undergoing surgeries which do not need general anesthesia or placement of endotracheal tube.

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr H S Murthy

Manipal Hospital

研究点 (1)

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