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临床试验/CTRI/2024/03/064796
CTRI/2024/03/064796尚未招募Post Marketing Surveillance

Intravenous dexmedetomidine versus propofol for moderate intraoperative sedation during brachial plexus block in orthopedic surgeries

BRLSABVM Medical college1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年4月15日最近更新:

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

发起方
BRLSABVM Medical college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pooja Paul

BRLSABVM medical college

研究点 (1)

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