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临床试验/CTRI/2024/03/064677
CTRI/2024/03/064677已完成Unknown

Dexmedetomidine and fentanyl as adjuvants to propofol based total intravenous anaesthesia in patients undergoing elective supratentorial craniotomies for intracranial space occupying lesions: A randomized controlled trial

ALL INDIA INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
82
试验地点
1
主要终点
To assess the mean propofol consumption at the end of the surgery (in mcg/kg/min) in all the patients.

研究概览

简要总结

Patients will be randomly allocated into two groups (Group A and Group B) using a computer-generated table.

Group A: Dexmedetomidine will be used as an adjuvant to propofol-based TIVA.

Group B: Fentanyl will be used as an adjuvant to propofol-based TIVA

All patients will be shifted to the operating room, where ASA standard monitors will be attached and heart rate (HR), mean arterial pressure (MAP), systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SpOâ‚‚) and electrocardiogram (ECG) will be noted. BIS monitoring sensors will be attached to monitor the depth of anaesthesia. BIS monitoring consists of a sensor, a digital converter and a monitor. It involves the application of four electrodes on the forehead, which pick up signals from the cerebral cortex and transfer them to the digital signal converter. The forehead will be cleaned with an alcohol-based solution and digital pressure applied over the sensor leads before placement (23).

All the patients will be pre-oxygenated with an appropriately sized face mask with 100% oxygen for 3 minutes. Induction will be done according to the allocated group.

Group A: Patients in this group will receive a loading dose of intravenous dexmedetomidine 1 mcg/kg over 10 minutes followed by a maintenance dose of 0.5 mcg/kg/hr. Titrated doses of intravenous propofol will be administered as a bolus to achieve BIS 40-60. After checking the ability to mask ventilate, 0.1mg/kg vecuronium will be administered intravenously. After three minutes of mask ventilation, the airway will be secured with an appropriately sized endotracheal tube. Dexmedetomidine infusion will be continued at the maintenance dose of 0.5mcg/kg/hr. Propofol infusion will be initiated at 100mcg/kg/min and titrated to BIS 40-60.

Group B: Patients in this group will be induced anaesthesia with 2mcg/kg of intravenous fentanyl followed by intravenous propofol 2-2.5mg/kg. After checking the ability to mask ventilate, 0.1mg/kg vecuronium will be administered intravenously. After three minutes of mask ventilation, the airway will be secured with an appropriately sized endotracheal tube. Fentanyl infusion will be initiated at a dose of 1mcg/kg/hr. Propofol infusion will be initiated at 100mcg/kg/min and titrated to BIS of 40-60.

The hemodynamic parameters such as HR, MAP, SBP and DBP will be noted throughout the surgery at predetermined intervals. Urine output will be monitored at hourly intervals. All patients will be ventilated with an oxygen and air mixture at a ratio of 1:1, 6-8 ml/kg of tidal volume, I: E ratio of 1:2, positive end-expiratory pressure (PEEP) of 5cm of Hâ‚‚O and the respiratory rate adjusted to maintain an end-tidal carbon dioxide (EtCOâ‚‚) of 30-35mmHg. Intermittent intravenous vecuronium boluses will be given to all the patients. Fluid management will be based on standard hemodynamic monitoring: aiming to sustain a MAP ≥ 65 mmHg, systolic pressure variation (SPV) below 13%, hematocrit (HCT) ≥ 30% and ensuring urinary output ≥ 0.5 ml/kg/hour. The MAP will be maintained at a level of ± 20% compared to the baseline. Baseline MAP will be defined as the average value of the first three MAP measurements from preoxygenation to induction. If the MAP increases or decreases by more than 20% of baseline values, the rate of fluid infusion will be adjusted, and a vasopressor or an antihypertensive agent, like esmolol or labetalol, will be given accordingly. The intraoperative nasopharyngeal temperature will be maintained between 36 Â°C and 37 Â°C. The amount of blood loss during the surgery will be assessed from the collection container in the suction apparatus, craniotomy drape and the mopping pads used during the surgery. The total amount of fluids given to the patient throughout the surgery will be noted.

Propofol infusion will be discontinued after completion of scalp sutures. The oropharynx will be gently suctioned using a soft suction catheter. The neuromuscular block will be reversed with intravenous neostigmine (0.05 mg per kg) & glycopyrrolate (0.01 mg per kg). The trachea will be extubated after objective extubation criteria are met. The entire duration of the surgery will be noted. Patients, who are not extubated, will be shifted to the intensive care unit (ICU).

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 70.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18-70 years of age including all genders.
  • American Society of Anaesthesiologists Physical status I to III.
  • Scheduled for elective craniotomy for supratentorial brain tumors under general anaesthesia.

排除标准

  • Patients refusing to give consent.
  • Patient with body mass index ≥ 35 kg/m².
  • Pregnant patients.
  • Patients allergic to any of the study drugs.
  • Preoperative GCS less than
  • Patients with bleeding diathesis.

结局指标

主要结局

To assess the mean propofol consumption at the end of the surgery (in mcg/kg/min) in all the patients.

时间窗: At the end of the surgery

次要结局

  • To compare the intra-operative hemodynamic profile between the two groups.(At 5-minute intervals till 15 minutes after induction, followed by every 30 minutes till the end of the surgery)

研究者

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

SRINIVASAN

Department of Anaesthesiology and Critical care, AIIMS Bathinda

研究点 (1)

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