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临床试验/CTRI/2024/01/061650
CTRI/2024/01/061650尚未招募3 期

A comparative study on the efficacy of Dexmedatomidine and Fentanyl as a local anaesthetic adjuvant to Levobupivacaine 0.125% in epidural labour analgesia- A randomized controlled study

Mukesh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
TO COMPARE THE ANALGESIC EFFECTS IN BOTH THE GROUPS FOR THE MOTHER

研究概览

简要总结

A Comparative study on the efficacy of Dexmedetomidine and Fentanyl as a local anesthetic adjuvant to Levobupivacaine 0.125% in epidural labor analgesia : Randomized controlled study in a tertiary care hospital kancheepuram district

PRIMARY OBJECTIVE

To compare the analgesic effects  of two drugs in epidural anesthesia in antenatal mother

SECONDARY OBJECTIVE

To compare the variables like,

Heart rate, Mean blood pressure, and Spo2

Adverse reactions of parturient women

DATA COLLECTION PROCESS:

Pre anesthetic checkup will be done and those patients who fit into the inclusion criteria will be taken up for the study. Study will be started after ethical committee and institutional committee approval . CTRI registration will be done before enrolling patient to the study.

• NPO of 6 hours for solid foods and 4 hours for liquids (prior to the procedure) will be ensured in all the patients. They would be pre medicated in the night before surgery followed by Inj. Pantoprazole 40 mg IV on the morning of surgery. IV access with 18G venflon secured in all patients. Monitors- Pulse oximeter, NIBP, ECG. ETCO2, Baseline values will be noted.

• Patients will be randomized into two groups 1 and 2 by the computer-generated technique.

• Group 1 includes 12 ml of 0.125% levobupivacaine with 0.5mcg/kg dexmedetomidine

• Group 2 includes 12 ml of 0.125% levobupivacaine with 2mcg/ml fentanyl

• Patients will be monitored for the following

• Blood pressure and heart rate will be monitored noninvasively.

• Intra and postoperative complications if any will be noted.

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 40.00 Year(s)(—)
性别
Female

入选标准

  • Age> 18 years Full term primigravida with singleton pregnancy (>37 weeks gestation) and required labor analgesia in hospital Patients who met the criteria for American Society of Anaesthesiology physical status I/II Patients willing to participate in the trial.

排除标准

  • Severe Heart, Lung, Liver and Kidney diseases,hemorraghic diseases or other systemic diseases 2)Known genteic or congenital malformations, fetal growth restrictions or Oligohydramnios.
  • Lower abdominal or urological surgery history, spinal deformity or previous spinal surgery.

结局指标

主要结局

TO COMPARE THE ANALGESIC EFFECTS IN BOTH THE GROUPS FOR THE MOTHER

时间窗: Intraoperative period

次要结局

  • COMPARING THE EFFECTIVENESS OF DEXMEDETOMIDINE AND FENTANYL AS A LOCAL ANESTHETIC ADJUVANT TO LEVOBUPIVACAINE IN EPIDURAL LABOR ANELGESIA(Intraoperative period.)

研究者

发起方
Mukesh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MUKESH

Shri Sathya Sai Medical College and Research Institute

研究点 (1)

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