跳至主要内容
临床试验/CTRI/2025/09/094550
CTRI/2025/09/094550尚未招募不适用

A prospective observational study to compare neuromuscular blockade recovery time with Train of Four after extubation when Atracurium is used as muscle relaxant In Laparoscopic versus open abdominal surgery

Dr Ibrahim khan1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
Comparison of Neuromuscular Blockade Recovery Time Using Train of Four Monitoring After Extubation with Atracurium in Laparoscopic versus Open Abdominal surgery

研究概览

简要总结

After obtaining approval from institutional ethical committee and written informed consent from all 54 patients as per sample size,  fulfilling the inclusion criteria, thorough pre-operative evaluation will be done. All the patients will be divided into two groups- GROUP A (Laparoscopic abdominal surgery) and GROUP B (Open abdominal surgery).

General Anaesthesia management for both the groups will be done according to the standard protocol including- Inj. Midazolam 0.05mg/kg, Inj. Fentanyl 2mcg/kg for premedication and sedation, Inj. Propofol 2mg/kg for induction. Intubation will be done under the effect of bolus dose of Inj. Atracurium 0.5mg/kg and maintenance will be done with O2, Air and Sevoflurane 1-3% with MAC of 0.8-0.9 using closed circuit. Intermittent dose of Inj. Atracurium 5mg as per the requirement will be given and total quantity will be noted.

Intra-operative vital parameters monitoring will be done including Pulse rate (PR), Blood pressure (BP), Oxygen saturation (SpO2), End-tidal carbon dioxide (ETCO2). Time of Reversal of NM Blockade will be decided by the anaesthesiologist after appearance of 1st Curare notch and extubation will be done. The time interval from last dose of Inj. Atracurium to the appearance of 1st Curare notch will be noted and ABG sample will be sent.

Then the time of completion of reversal and extubation will be noted accordingly. Quantitative assessment of recovery of NM Blockade will be confirmed with TOF Reading immediately after extubation. Patient will be monitored further in post operative care unit. To avoid confounding factors like effect of inhalational agent on muscle relaxation, concentration of sevoflurane will be monitored till the end of surgical procedure and MAC will be Recorded.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • patient undergoing laparoscopic and open abdominal surgeries patient categories under American society of Anesthesiologist(ASA) Grade 1 and 2.

排除标准

  • patient with pre-existing Asthma, chronic bronchitis, Allergic rhinitis patient having hypersensitivity to Atracurium patient not willing to participate in the study.

结局指标

主要结局

Comparison of Neuromuscular Blockade Recovery Time Using Train of Four Monitoring After Extubation with Atracurium in Laparoscopic versus Open Abdominal surgery

时间窗: Train of Four monitoring post extubation every 5min till TOF ratio 0.9

次要结局

  • to study spontaneous recovery time from last dose of Atracurium to appearance of curare notch(To compare the ABG parameters in both groups at the beginning of reversal)

研究者

发起方
Dr Ibrahim khan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ibrahim Khan

Bharati vidyapeeth deemed to be university dhankawadi pune,

研究点 (1)

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