Intravenous dexmedetomidine versus propofol for moderate intraoperative sedation during brachial plexus block in orthopedic surgeries
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Level of sedation assessed by Ramsay Sedation Scale
研究概览
简要总结
I want to conduct a "comparative study between intravenous dexmedetomidine versus propofol for moderate intraoperative sedation during brachial plexus block in orthopedic surgeries"
AIM: To study the sedation characteristics of dexmedetomidine and propofol infusion for intraoperative moderate sedation in patients undergoing brachial plexus block in elective orthopedic surgeries.
OBJECTIVES: i) Level of sedation using Ramsay sedation score
ii) Alertness of the patient using modified observer’s assessment of alertness/sedation score (MOAA/S)
SETTING: B.R.L.S.A.B.V.M. Medical College, Rajnandgaon, C.G.
STUDY DESIGN: Prospective, randomized, interventional study
TIME FRAME: April 2024 to June 2024
STUDY POPULATION/PARTICIPANTS: Patients posted for elective orthopedic surgeries undergoing brachial plexus block at B.R.L.S.A.B.V.M. Medical college, Rajnandgaon.
SAMPLE SIZE: The sample size of the study will be taken as 44 with 22 in each group
METHOD: Informed & written consent, Preoperative monitoring, IV access, Brachial plexus block- Interscalene block/ Supraclavicular block/ Axillary block, Proposed surgery, Postoperative monitoring
OUTCOME MEASURES:
I) PRIMARY:
Level of sedation assessed by Ramsay Sedation Scale
Alertness of the patient assessed by Modified Observers Assessment of Alertness/Sedation
II) SECONDARY:
Mean arterial BP, HR, RR , arterial oxygen saturation
Incidence of adverse effects
Duration of sedation
Type of brachial plexus block
Duration of surgery
Intraoperative requirement of ephedrine
VAS score for pain
Patient satisfaction score
STATISTICAL ANALYSIS
Statistical analysis will be performed by the SPSS program for Windows, version 20.0. Continuous variables will be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test.
研究设计
- 研究类型
- Pms
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •ASA I-II BMI 18.5-35 Patients undergoing elective orthopedic surgeries under brachial plexus block.
排除标准
- •Hemodynamic instable patients Allergy to any of study medication Known hypersensitivity to local anaesthetics Pregnancy Infection at the site of block Pre existing peripheral neuropathy Patient refusal.
结局指标
主要结局
Level of sedation assessed by Ramsay Sedation Scale
时间窗: RSS at every 5 minutes till end of surgery | MOAA/S at every 5 minutes till end of surgery
Alertness of the patient assessed by Modified Observers Assessment of Alertness/Sedation
时间窗: RSS at every 5 minutes till end of surgery | MOAA/S at every 5 minutes till end of surgery
次要结局
- Mean arterial BP, HR, RR , arterial oxygen saturation Incidence of adverse effects Duration of sedation Type of peripheral nerve block Duration of surgery Intraoperative requirement of ephedrine VAS score for pain Patient satisfaction score(BP at every 5 minutes till end of surgery)
研究者
Dr Pooja Paul
BRLSABVM medical college
