Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
- Conditions
- Cesarean Section Complications
- Interventions
- Registration Number
- NCT04095013
- Lead Sponsor
- Dow University of Health Sciences
- Brief Summary
the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
- Detailed Description
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Term pregnancy Singleton ASA I and II, BMI <35, elective C/section
patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group BF Bupivacaine, fentanyl hyperbaric Bupivacaine 10mg with fentanyl 10micrograms Group BD Bupivacaine, dexmedetomidine hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
- Primary Outcome Measures
Name Time Method Regression time to T10 dermatome (Min) Post operative initial hour Spinal block characteristics
Time of complete motor recovery (Min) Post operative initial hour Spinal block characteristics
Time of maximum bromage achieved (Sec) Post operative initial hour Spinal block characteristics
Time till T10 dermatome achieved (Sec) Post operative initial hour Spinal block characteristics
Post-operative pain score 4 hour VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
- Secondary Outcome Measures
Name Time Method Nausea 24 hours Post operative Sensation to throw out stomach contents
Pruritus 24 hours Post operative Unpleasing sensation on the skin that provokes to scratch
Hypotension 24 hours Post operative Decrease in BP greater than 20% of baseline
Vomiting 24 hours Post operative Act of throwing out stomach contents through mouth
Bradycardia 24 hours Post operative Heat rate less than \<60 bpm
Respiratory distress 24 hours Post operative Difficulty in breathing
Shivering 24 hours Post operative The act of shaking slightly and uncomfortably due to felling of cold temperature
Trial Locations
- Locations (2)
DUHS, Civil hospital Karachi (CHK)
🇵🇰Karachi, Sindh, Pakistan
Civil Hospital Karachi
🇵🇰Karachi, Sindh, Pakistan