Comparison of Dexmedetomidine and Fentanyl for prevention of emergence agitation in adult patients after laparoscopic surgeries under Sevoflurane anaesthesia. A randomised double blinded study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To determine the effectiveness in prevention of emergence agitation, using the drugs Inj. Dexmedetomidine and Inj. Fentanyl in patients undergoing laparoscopic surgeries after Sevoflurane Anaesthesia.
研究概览
简要总结
| This study is a randomized double-blind study to compare the effectiveness of Inj. Dexmedetomidine and Inj. Fentanyl in the prevention of emergence agitation in adult patients undergoing laparoscopic surgeries under Sevoflurane Anesthesia. Problems of post-anesthesia emergence have been shown to occur in 5–10% of general surgery patients of all ages. Inhalation anesthetics, especially Sevoflurane, are also a potential risk factor for emergence agitation. Various medications have been used for the prevention of emergence agitation after general anesthesia which includes ketamine, propofol, opioids, and Dexmedetomidine. Here, is the comparison of Dexmedetomidine with Fentanyl. |
Randomization: Patients will be randomly divided into two groups pre-operatively using computer-generated randomization.(www.randomiser.org)
Group (D): (n=36) In this group patients will be given Inj. Dexmedetomidine in the dose of 1 mcg/kg IV. 1 ml of Inj. Dexmedetomidine will be taken and diluted to 10 ml to prepare a concentration of 10 mcg/ ml
Group (F): (n=36) In this group, patients will be given Inj. Fentanyl in the dose of 1 mcg/kg IV. Here, 2 ml of the drug will be taken and diluted to 10 ml to prepare a concentration of 10 mcg/ml.
MONITORING OF PARAMETERS:
Intraoperatively:
o Blood pressure, Heart rate, SpO2, and ET-CO2 will be recorded just before Inj. Dexmedetomidine or Inj. Fentanyl administration(T0), just after administering Inj. Dexmedetomidine or Inj. Fentanyl loading dose administration(T1), 5, 10, 15 minutes(T2, T3, T4) after induction then every 30 minutes after the induction (T5,T6,T7), and at the end of the surgery(T8).
o Emergence time will be noted. Emergence time is the time from discontinuation of anesthetics to extubation. (TE)
Postoperatively: Patient’s Blood pressure, pulse rate, SpO2, and agitation will be noted till 24 hours post-extubation. Initially every 10 minutes for 1 hour and then hourly till 4 hours post-extubation and then 4 hourly till 24 hours postextubation. The incidence of Agitation will be noted. Agitation score using the Riker sedation agitation score 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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective laparoscopic surgery.
- •Patients conformed to American Society of Anaesthesiologists (ASA) physical status I-II in preoperative assessment.
排除标准
- •Inability or refusal to follow the study protocol.
- •Patients with mental retardation, history of agitation, coagulation disorder, dementia, cerebral insult, intracranial surgery.
- •Patients with known allergy to the study drugs.
结局指标
主要结局
To determine the effectiveness in prevention of emergence agitation, using the drugs Inj. Dexmedetomidine and Inj. Fentanyl in patients undergoing laparoscopic surgeries after Sevoflurane Anaesthesia.
时间窗: Emergence time will be noted. Emergence time is the time from discontinuation of anaesthetics to extubation. | Incidence of Agitation will be noted, | Agitation score using the Riker sedation agitation score will be noted. | This will be noted upto 24 hours post-operatively
次要结局
- 1. To determine incidence of emergence agitation for 24 hours post operatively after using Sevoflurane during laparoscopic surgeries.(2. To compare hemodynamic stability in patients given Inj. Dexmedetomidine or Inj. Fentanyl undergoing laparoscopic surgeries under general anaesthesia with Sevoflurane.)
研究者
Phalguni
Government Medical College, Vadodara