The effect of Intranasal Dexmedetomidine on Hemodynamic responses during Double Lumen Tube insertion- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the Hemodynamic responses between Dexmedetomidine and Placebo given in addition to drugs used in our current standard of care during laryngoscopy and DLT insertion
研究概览
简要总结
Tracheal intubation and laryngoscopy may cause sympathetic stimulation, which can cause tachycardia and hypertension. To abolish the pressor response to laryngoscopy and endotracheal intubation, many medication combinations have been tried with varying degrees of efficacy.
The purpose of this study is to evaluate the effect of Intranasal Dexmedetomidine on hemodynamic responses to laryngoscopy and endobronchial intubation with a double lumen tube. Patients coming for elective lung surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period.
Patients will be divided into two groups by computer-generated block randomization: Group A will receive Intranasal dexmedetomidine (1mcg/kg) diluted in 2 ml syringe and Group B will receive placebo (0.9 % saline) in 2 ml syringe in equal volume into both nostrils.
Patients in pre induction room, after connecting to standard ASA monitors – ECG, Pulse Oximetry, Blood Pressure, study drug will be administered belonging to either Group A (Dexmedetomidine) or Group B (Placebo). 45 minutes after administration of the study drug, patients will be wheeled into Operating Theatre. After connecting standard ASA monitors, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 1 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital. Anaesthesia will be maintained with sevoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and DLT insertion will be performed by an anaesthesiologist at the level of final year MD registrar or above. If the first attempt by the registrar is unsuccessful, subsequent attempts will be done by the senior anaesthesiologist posted on the list.
Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 3-6mg or Phenylephrine 25-50 mcg. Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypotension and bradycardia will be documented and the number of doses of rescue medication administered will be noted. The total laryngoscopy and DLT insertion time, total fiberoptic bronchoscopy time and total isolation time will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing elective lung surgery including pulmonary lobectomy, pneumonectomy, metastasectomy, decortication, etc who require Left sided DLT placement ASA Physical status I to III.
排除标准
- •Patients with difficult airway
- •Surgeries requiring Right sided Double Lumen Tube insertion
- •Uncontrolled hypertensives
- •Heart disease with ejection fraction less than 40%
- •Body mass index more than 35 kg/ m2
- •History suggestive of sensitivity to drugs used during the study
- •Patients with bradycardia (heart rate < 50 beats per minute) or any heart block
- •Nasal pathology
- •History of reactive airway disease
- •Hepatic or Renal impairment 11.
结局指标
主要结局
To compare the Hemodynamic responses between Dexmedetomidine and Placebo given in addition to drugs used in our current standard of care during laryngoscopy and DLT insertion
时间窗: 1 hour
次要结局
- 1. To assess the requirement of additional anaesthetic drugs ( fentanyl, propofol) in order to maintain the hemodynamics within 20% of baseline values during Laryngoscopy and DLT insertion(2. To assess the incidence of hypotension and bradycardia during drug administration and during laryngoscopy and DLT insertion)
研究者
Roys Prathima G
Christian Medical College
