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临床试验/CTRI/2026/03/0105118
CTRI/2026/03/0105118尚未招募Unknown

Automated vs. Manual Control of Isoflurane Delivery for Quality and Recovery in Adult Surgical Patients Under General Anesthesia: An open-label randomised controlled trial

JIPMER Puducherry1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2026年3月11日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
76
试验地点
1
主要终点
Time taken for recovery from amesthesia - vocal response and tongue protrusion

研究概览

简要总结

This study aims at establishing the benefits of Et control mode of anesthesia agent delivery by GE Aisys CS2 anesthesia machine. We compare intra operative hemodynamics of the patient and recovery from anesthesia as a tool to compare manual mode and Et control mode with respect to the cost incurred in both these modes respectively.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 to 3 patients.
  • Patients undergoing surgery with general anesthesia.
  • Intubated with PVC Endo tracheal tube.

排除标准

  • Patient undergoing additional regional anesthesia technique.
  • Patients not willing to participate in the study.
  • Patients whose expected surgery duration is less than 3 hours.
  • Pregnant/ Lactating mothers.
  • Patient with psychiatric/ neurological disease/ taking any CNS drugs.
  • Patients with any pre existing psychiatric conditions on medication.

结局指标

主要结局

Time taken for recovery from amesthesia - vocal response and tongue protrusion

时间窗: baseline value - only one value taken

次要结局

  • To compare time between stopping of isoflurane and tracheal extubation(To compare time between stopping of isoflurane and tracheal extubation)
  • to estimate percent time BIS deviation from target +/- 10% between two study groups(through out surgery duration BIS monitoring)
  • To estimate percent time Heart rate and mean arterial pressure deviation between two study groups(Throughout surgery HR and MAP monitoring at every 5 mins interval)
  • To compare the total amount of isoflurane used throughout the surgery in two study groups.(Value obtained from GE Aisys CS2 at the end of each surgery.)
  • To comapre the total amount of fresh gases, oxygen, nitrous oxide used in the surgery in two study groups(Values obtained from GE Aisys CS2 anesthesia machine at the end of each surgery)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Afreed A

JIPMER - Puducherry

研究点 (1)

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