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临床试验/CTRI/2023/04/051598
CTRI/2023/04/051598尚未招募4 期

COMPARISON BETWEEN INTRATHECAL FENTANYL AND DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC 0.5% LEVOBUPIVACAINE IN SUBARACHNOID BLOCK FOR CEASAREAN SECTION: A PROSPECTIVE STUDY

Office of the Principal, Midnapore Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年4月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
We are using equipotent dose of fentanyl and dexmedetomidine and both increases the duration of sensory & motor block. we expect both the groups receiving fentanyl and dexmedetomidine will have a longer duration of sensory & motor block compared to patients receiving

研究概览

简要总结

PROPOSEDTOPIC OF RESEARCH:Comparison between intrathecal fentanyl and dexmedetomidine as an adjuvant tohyperbaric 0.5% levobupivacaine in subarachnoid block for caesarean section: Aprospective study.

OBJECTIVEOF PROPOSED RESEARCH:To compare the duration of sensory and motor block between fentanyl anddexmedetomidine when administered intrathecally as adjuvant to 0.5% hyperbaric levobupivacainein spinal anaesthesia for elective lower segment caesarean section.

Background of present study: In recent years levobupivacaine, the pure S(−)-enantiomer of bupivacaine, emerged as a safer alternative for regionalanesthesia than its racemic parent. Recently 0.5% hyperbaric levobupivacaine hasbeen introduced in clinical practice and widely used as a substitution of 0.5%hyperbaric bupivacaine in spinal anaesthesia.

Toprolong the duration of sensory and motor block many adjuvants have beenpreviously added to 0.5% hyperbaric bupivacaine in spinal anaesthesia. Fentanyland dexmedetomidine both have been profoundly used as adjuvant with 0.5%hyperbaric bupivacaine in cesarean section. As there is no published data onthe effect of adjuvants with hyperbaric levobupivacaine we propose to comparethe effects of fentanyl and dexmedetomidine with 0.5% hyperbariclevobupivacaine in caesarean section.

Methodology: After ethicalclearance and written informed consent, 105 mothers undergoing electivecaesarean section will be randomly allocated into three groups. Group F will receivedintrathecal fentanyl 25 mcg (0.5 ml) along with 1.8 ml of 0.5% hyperbaric levobupivacaine,group D will received intrathecal dexmedetomidine 5 mcg (prepared in 0.5 ml ofnormal saline) along with 1.8 ml of 0.5% levobupivacaine and group C will begiven 0.5 ml of normal saline along with same dose of 0.5% of hyperbaric levobupivacaine.Maximum level of sensory block, time for two segment regression of sensoryblock and duration of motor block will be recorded. Post operative analgesiawill be assessed by using visual analogue score (VAS) and patients complainingof VAS>4 will be given rescue analgesia. Time of first dose ofpost-spinal rescue analgesic will be noted.

 Expected outcome: As there is no previous published data comparing fentanyl anddexmedetomidine as adjuvant with 0.5% hyperbaric levobupivacaine, we acceptthat there will be no difference regarding the duration of sensory and motorblock in these two groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade II
  • Age group of 18-30 years
  • Body Mass Index between 18.5 and
  • Gestational age ≥37 weeks
  • Elective lower segment caesarean section under spinal anaesthesia.

排除标准

  • Patients with severe cardio-respiratory disease
  • Patients with hepatic & renal disease
  • Patients with neurologic disorder
  • Patients with endocrine disorder
  • Patients with H/O Antepartum Hemorrhage (APH)
  • Subarachnoid block inadequate or failure
  • Drug allergy to study drugs.

结局指标

主要结局

We are using equipotent dose of fentanyl and dexmedetomidine and both increases the duration of sensory & motor block. we expect both the groups receiving fentanyl and dexmedetomidine will have a longer duration of sensory & motor block compared to patients receiving

时间窗: September 2022 to February 2024

normal saline as adjuvant but among fentanyl and dexmedetomidine which one will provide longer duration of sensory & motor block will be known after cpmpletion of the study.

时间窗: September 2022 to February 2024

次要结局

  • Duration of surgery(from the beginning to end ot surgery)
  • to measure Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, VAS Score, ECG(baseline)
  • Apgar score of neonates(at 1 min and 5 min after delivery)

研究者

发起方
Office of the Principal, Midnapore Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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