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临床试验/CTRI/2024/06/069417
CTRI/2024/06/069417尚未招募4 期

A Randomized Study to Compare Efficacy of Combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in Head and Neck Cancer patients for Awake Flexible Nasotracheal Intubation in Department of Anaesthesia SMS Medical College Jaipur

Department of Anesthesiology Sawai Mansingh Medical College Jaipur Rajasthan1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年7月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
1-Mean time required for intubation in minutes

研究概览

简要总结

Awake nasotracheal intubation is recommended technique for securing airway in patients with anticipated difficult intubation while keeping the patient concious but sedated with intact respiratory drive to ensure better patient comfort and cooperation during the procedure.This study aims to compare the efficacy of combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in head and neck cancer patients for awake flexible nasotracheal intubation. For this a total of eighty four patients ( n=84) undergoing surgery for head and neck cancer fulfilling the inclusion criteria will be divided into two groups of 42 patients each Group A and B. Group A patients will be receiving Midazolam 0.03mg/kg and an infusion of Dexmedetomidine 1mcg/kg diluted in 50 ml saline over 10 minutes whereas group B will be receiving Midazolam 0.03mg/kg and an infusion of Fentanyl 2mcg/kg diluted in 50 ml saline over 10 minutes. Level of sedation will be assessed using modified Observers Assessment of Alertness Sedation Score (OAA/S) . After adequate Sedation intubation will be done using flexible bronchoscope and the position of endotracheal tube will be confirmed by end tidal capnography . Anaesthesia will be induced and maintained. After completion of the surgery all anaesthetic agents will be withdrawn , residual neuromuscular block will be reversed with injection Neostigmine 0.06mg/kg and injection Glycopyrrolate 0.001mg/kg . Patient will be extubated when fully awake having good motor power and obeying verbal commands following which the patient will be shifted to recovery room and monitored. 2 hours post extubation patient will be evaluated for recall of the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patient undergoing head and neck cancer surgeries requiring awake nasotracheal intubation with flexible bronchoscope, patient willing to participate in the study, adult patient aged between 30-70 years of either gender, patient belonging to ASA grade I,II,III.

排除标准

  • Patients with history of obstructive sleep apnoea, nasal trauma, nasal surgery and bleeding diathesis, patient with history of allergy to the study drugs, non-cooperative or mentally retarded patients.

结局指标

主要结局

1-Mean time required for intubation in minutes

时间窗: 1-Baseline | 2-10 minutes after the drug infusion | 3-one minute post intubation

2-Sedation score-Observers Assessment of Alertness score/Sedation Score (OAA/S)

时间窗: 1-Baseline | 2-10 minutes after the drug infusion | 3-one minute post intubation

3-ease of intubation score

时间窗: 1-Baseline | 2-10 minutes after the drug infusion | 3-one minute post intubation

次要结局

  • Mean of Haemodynamic parameters (HR,SpO2, SBP, DBP, MAP), proportion of cases with complications, recall of procedure(Just after surgery, 1 hour after surgery)

研究者

发起方
Department of Anesthesiology Sawai Mansingh Medical College Jaipur Rajasthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sushil Kumar Bhati

SMS Medical College Jaipur

研究点 (1)

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