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临床试验/CTRI/2023/09/057760
CTRI/2023/09/057760尚未招募Phase 3 4

Comparative study of intranasal and intravenous dexmeditomidine for attenuation of haemodynamic responses to laryngoscopy and endotracheal intubation in adult surgical patients under general anaesthesia

Vardhman Mahavir Medical College New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月25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
100
试验地点
1
主要终点
Mean arterial pressure{MAP}

研究概览

简要总结

METHODOLOGY

All patients satisfying inclusion criteria will undergo detailed preanaesthetic evaluation. After explaining the nature of the study, an informed consent will be obtained from all patients willing to participate in the study, followed by a complete physical examination.

100 adults, will be included in this study. All patients will be randomly allocated to one of study groups using computer generated randomization. The patients will be then divided into two groups Group -A(Intravenous dexmeditoidine) and Group B(Intranasal dexmeditomidine). All patients of both groups will be advised for fasting of 6 hours and premedication of tablet ranitidine (150 mg) and alprazolam (0.5 mg) on the night before surgery.

On the day of operation, all patients will be shifted to preoperative room 2 h before the operation time. Monitoring like electrocardiography (ECG), plethysmography (SPO2), non- invasive blood pressure (NIB) monitoring will be attached and baseline readings will be obtained. Intravenous access(18G) will be secured and IV Ringer’s lactate solution will be administered as maintenance fluid. The study drug will be prepared and given by some senior anaesthesiologist and monitoring of parameters will be done by different anaesthesiologist.

Group A(Dexmeditomidine intravenous) will be given IV DEXMEDITOMIDINE (0.50 ug/kg) diluted in 40 ml of normal saline (NS) through an infusion pump over 40 min and I ml of NS intranasal will be instilled in equal volume in both nostrils before induction at the same time.

Group B(Dexmeditomidine intranasal) will be instilled Im| DEXMEDITOMIDINE in both nostrils in equal volume and 40ml of normal saline (NS) intravenously through an infusion pump over 40 min before induction. All the patients of both groups will be advised not to sneeze or suck after intranasal drug administration.

Then after completion of study drug administration, patient will be shifted in the operation room, standardised monitoring like electrocardiography (ECG), plethysmography (SP02). noninvasive blood pressure (NIBP), End tidal carbondioxide (EtCO2) monitoring will be connected and before induction readings will be noted.

All patients will be pre- oxygenated with 100% oxygen for 3 minutes. Fentanyl citrate 2 meg/kg, and titrated dose of Propofol 1-2 mg/kg will be given over 45second till the loss of consciousness . After ensuring check ventilation , vecuronium bromide 0.1 mg/kg body weight will be administered intravenously. Patient will be ventilated with mixture of oxygen + NO(50:50) and Isoflurane (MAC- 1) for 4 min and then endotracheal intubation with appropriate cuffed endotracheal tube will be performed. After confirming for bilateral equal airentry, the endo-tracheal tube will be fixed and normocapnic ventilation will be started with monitoring of ECG, HR, NIBP/IBP, EtCO2 and SpOz Readings at 2,5,7and 9 minutes after intubation will be noted Maintenance of anaesthesia will be continued with 02 + NO(40:60) and Isoflurane (MAC-1) All haemodynamic parameters will be monitored continuously and any adverse events like bradycardia, tachycardia, hypertension, hypotension or arrhythmia will be recorded and appropriate management will be done. Additional doses of neuromuscular blockade i.e. inj. vecuronium bromide 0.025mg/kg as and when required and analgesic inj. fentanyl 1meg/kg one and hourly would be given according to duration of surgery. Inj Ondansetron 4mg intravenous will be given 30 min before end of surgery.

After completion of surgery, neuromuscular block will be reversed by appropriate dose of IV neostigmine (0.05 mg/kg) and glycopyrolate (0.01 mg/kg).

After adequate muscle power recovery patient will be extubated and will be shifted to the recovery room after stabilization Patents vitals will be monitored there for 2 h and when Modified Alderate score ›9, the patient will be shifted to ward.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • 1.Adult patients belonging to ASA grade I &II 2.Scheduled for elecytive surgery under general anaestheia.

排除标准

  • Uncooperating, non consenting patients.
  • Known allery or hypersenstivity to dexmeditomidine.
  • Pregnant, lactating mothers, Cardiac or respratory disease, uncontrolled hypertension, diabetes mellitus type II, neurological or psychiatric disease, or any intranasal pathology{like nasal ulcers, polyps, nasaal septal deviation}.

结局指标

主要结局

Mean arterial pressure{MAP}

时间窗: 40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction.

次要结局

  • Systolic blood pressure{SBP}, diastolic blood pressure{DBP} & heart rate.(40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction.)

研究者

发起方
Vardhman Mahavir Medical College New Delhi
申办方类型
Government medical college

研究点 (1)

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