Comparative evaluation of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in ultrasound guided Superficial Cervical Plexus Block for post operative analgesia in patients undergoing mastoid surgery .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time of first rescue analgesia post operatively
研究概览
简要总结
Study Title:Comparative evaluation of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block for post operative analgesia in patients undergoing mastoid surgery
Study Type: randomised controlled study
Objective: To compare the effect of dexamethasone versus dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block for post operative analgesia in patients undergoing mastoid surgery .
Participants: Patients of either sex , aged 18-60 yrs with American Society of Anaesthesiologist Physical Status I/II , BMI 18-30 kg/m2, scheduled for elective mastoid surgery under general anaesthesia .
Interventions:
Group A: Patients will be given Ultrasound guided Superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 4 mg dexamethasone as adjuvant .
Group B: Patients will be given Ultrasound guided Superficial cervical plexus block using 5 ml of 0.25% bupivacaine and 25mcg dexmedetomidine as adjuvant .
Primary Outcome: To evaluate and compare the duration of post operative analgesia using dexmedetomidine vs dexamethasone as an adjuvant to bupivacaine in ultrasound guided superficial cervical plexus block in patients undergoing mastoid surgery.
Secondary Outcomes:
To evaluate and compare:-
-
Post operative pain score (Numerical rating scale) for pain at 30 minutes, 1 hour, 4 hours, 8 hours, and 24 hours.
-
Post operative sedation score (Ramsay sedation scores) for sedation at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour.
-
Postoperative haemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate) at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour.
-
Total rescue analgesic requirement in first 24 hour postoperatively.
-
Incidence of PONV in first 24 hour postoperatively.
In both the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •1 Patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II 2 Body mass index 18 to 30 kg/m² 3 Patients undergoing elective mastoid surgery under general anaesthesia.
排除标准
- •Local infection at site of block
- •Bleeding disorders or patients on anticoagulants.
- •History of allergy to study drugs
- •Pregnant or lactating female 5.
结局指标
主要结局
Time of first rescue analgesia post operatively
时间窗: Time of first rescue analgesia post operatively
次要结局
- Post operative pain score (Numerical rating scale)(postoperatively at 30 minutes, 1 hour, 4 hours, 8 hours, and 24 hours.)
- Post operative sedation score (Ramsay sedation scores) for sedation(Post operatively at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour.)
- Postoperative haemodynamic parameters.(Postoperatively at 30 minutes, 1 hour, 4 hour, 8 hour, and 24 hour.)
- Total rescue analgesic requirement in first 24 hour postoperatively.
- Incidence of PONV in first 24 hour postoperatively.
研究者
Dr Akansha Chona
ESIC Medical College and Hospital, Faridabad