Comparison Between Opioid-Free Anesthesia vs Conventional Opioid-Based Anesthesia for Nasal Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Postoperative Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare the efficacy, onset, duration of action, analgesic effect, and side effects of opioid-free anesthesia using dexmedetomidine and lignocaine versus conventional opioid-based anesthesia using fentanyl in patients undergoing nasal surgeries, including functional endoscopic sinus surgery (FESS) and septoplasty. The main questions it aims to answer are:
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on VAS score ?
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on postoperative complications including nausea and vomiting , postoperative Ramsay sedation score, amount of rescue analgesia , hemodynamic stability and patient satisfaction ? patients will be divided into two equal groups:
- Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
- Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
the study is double-blinded (patient and outcome assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18 and 60, scheduled to undergo elective nasal surgeries.
- •ASA (American Society of Anesthesiologists) physical status I-II.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •ASA III or above.
- •Patients with a history of opioid dependence or chronic pain conditions requiring long-term opioid therapy.
- •Patients with multiorgan failure, unstable hemodynamics prior to surgery, or scheduled for emergency surgery.
- •Pregnant or lactating women.
- •Patients with a history of severe asthma or those taking preoperative alpha-blockers.
研究组 & 干预措施
dex and lido
this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
干预措施: dexmedetomidine and lignocaine infusion (Drug)
Fent
this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
干预措施: Fentanyl infusion (Drug)
结局指标
主要结局
Change From Baseline in Postoperative Pain Intensity
时间窗: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Postoperative pain intensity will be assessed using the Visual Analog Scale for Pain (VAS), which ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Baseline pain score will be defined as the VAS score measured immediately after arrival to the post-anesthesia care unit (PACU). The primary outcome will be the change from baseline in VAS pain scores at each postoperative assessment time point, comparing opioid-free and opioid-based anesthesia approaches
次要结局
- Change From Baseline in Mean Arterial Pressure(Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.)
- Change From Baseline in Heart Rate(Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.)
- Change From Baseline in Quality of Recovery Score (QoR-40)(Preoperatively (baseline) and 24 hours postoperatively.)
- Need for Rescue Analgesia(From the end of surgery up to 24 hours postoperatively.)
- Postoperative Nausea and Vomiting (PONV)(30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively.)
- Patient and Surgeon Satisfaction(24 hours postoperatively.)
- Postoperative Sedation Level (Ramsay Sedation Score)(30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.)
研究者
Ahmed Mohsen Zakaria Afia
Principal Investigator
Benha University