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临床试验/CTRI/2025/01/079197
CTRI/2025/01/079197尚未招募Phase 3 4

Emergence time following target-controlled versus manual controlled propofol infusion in patients undergoing endoscopic trans-sphenoidal pituitary surgery: A Prospective, Randomized, Controlled study

AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Time to respond to verbal commands following cessation of anaesthetic drug infusion.

研究概览

简要总结

Smooth and early emergence from anaesthesia prevents sudden rise in blood pressure and risk of complications such as bleeding while early recovery facilitates prompt neurological assessment and treatment of complications.  This study aims to compare the emergence time (from anaesthesia) between the target-controlled infusion (TCI) versus manual-controlled infusion (MCI) techniques of propofol infusion in patients undergoing elective endoscopic trans-sphenoidal pituitary surgery. The study will also asses the intraoperative hemodynamic variability, propofol and fentanyl consumption, time to tracheal extubation and aldretes’s score at 5 min between the two groups. The present study will provide insight whether use of target controlled infusion technique for propofol infusion will result in early and smooth recovery from anaesthesia over manual controlled technique  in patients undergoing elective endoscopic trans-sphenoidal pituitary surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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 undergoing elective endoscopic trans-sphenoidal pituitary tumour surgery, ASA physical Grade I & II.

排除标准

  • Refusal for consent, Emergency Surgery, Giant pituitary tumor more than 4cm, Tumors with major cavernous sinus infiltration and ICA encasement, Altered sensorium, Body Mass Index more than 35, Obstructive sleep apnoea, Psychiatric or psychological disorder, Anticipated difficult airway, History of any intracranial surgery in the past, Patients with Alcohol or substance abuse, Pregnant or lactating patient will be excluded from the study.

结局指标

主要结局

Time to respond to verbal commands following cessation of anaesthetic drug infusion.

时间窗: From nasal packing to tracheal extubation.

次要结局

  • Hemodynamics variability(Total consumption of propofol & fentanyl)

研究者

发起方
AIIMS, New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SANIYA JAISWAL

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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