Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Cesarean Section Complications Clinical Trial

Official title:

Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095013
• Other study ID #: dr.sanaurooj@yahoo.com
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: September 2019
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Term pregnancy Singleton ASA I and II, BMI <35, elective C/section

Exclusion Criteria:

patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Bupivacaine, fentanyl
Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
• Bupivacaine, dexmedetomidine
Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Locations

Country	Name	City	State
Pakistan	Civil Hospital Karachi	Karachi	Sindh
Pakistan	DUHS, Civil hospital Karachi (CHK)	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic Blood Pressure	Hemodynamics	Baseline
Other	Systolic Blood Pressure	Hemodynamics	Immediate after giving intrathecal injection and positoning
Other	Systolic Blood Pressure	Hemodynamics	at 5 minute
Other	SBP	Hemodynamics	at 10 minute
Other	Systolic Blood Pressure	Hemodynamics	at 15 minute
Other	Systolic Blood Pressure	Hemodynamics	at 20 minute
Other	Diastolic Blood Pressure	Hemodynamics	Baseline
Other	Diastolic Blood Pressure	Hemodynamics	Immediate after giving intrathecal injection and positoning
Other	Diastolic Blood Pressure	Hemodynamics	at 5 minute
Other	Diastolic Blood Pressure	Hemodynamics	at 10 minute
Other	Diastolic Blood Pressure	Hemodynamics	at 15 minute
Other	Diastolic Blood Pressure	Hemodynamics	at 20 minute
Other	Heart Rate	Hemodynamics	Baseline
Other	Heart Rate	Hemodynamics	Immediate after giving intrathecal injection and positoning
Other	Heart Rate	Hemodynamics	at 5 minute
Other	Heart Rate	Hemodynamics	at 10 minute
Other	Heart Rate	Hemodynamics	at 15 minute
Other	Heart Rate	Hemodynamics	at 20 minute
Other	oxygen saturation	Hemodynamics	Baseline
Other	oxygen saturation	Hemodynamics	Immediate after giving intrathecal injection and positoning
Other	oxygen saturation	Hemodynamics	at 5 minute
Other	oxygen saturation	Hemodynamics	at 10 minute
Other	oxygen saturation	Hemodynamics	at 15 minute
Other	oxygen saturation	Hemodynamics	at 20 minute
Other	respiratory rate	Hemodynamics	Baseline
Other	respiratory rate	Hemodynamics	Immediate after giving intrathecal injection and positoning
Other	respiratory rate	Hemodynamics	at 5 minute
Other	respiratory rate	Hemodynamics	at 10 minute
Other	respiratory rate	Hemodynamics	at 15 minute
Other	respiratory rate	Hemodynamics	at 20 minute
Primary	Time till T10 dermatome achieved (Sec)	Spinal block characteristics	Post operative initial hour
Primary	Time of maximum bromage achieved (Sec)	Spinal block characteristics	Post operative initial hour
Primary	Regression time to T10 dermatome (Min)	Spinal block characteristics	Post operative initial hour
Primary	Time of complete motor recovery (Min)	Spinal block characteristics	Post operative initial hour
Primary	Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	1 hour
Primary	Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	2 hour
Primary	Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	3 hour
Primary	Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	4 hour
Secondary	Nausea	Sensation to throw out stomach contents	24 hours Post operative
Secondary	Vomiting	Act of throwing out stomach contents through mouth	24 hours Post operative
Secondary	Pruritus	Unpleasing sensation on the skin that provokes to scratch	24 hours Post operative
Secondary	Respiratory distress	Difficulty in breathing	24 hours Post operative
Secondary	Shivering	The act of shaking slightly and uncomfortably due to felling of cold temperature	24 hours Post operative
Secondary	Bradycardia	Heat rate less than <60 bpm	24 hours Post operative
Secondary	Hypotension	Decrease in BP greater than 20% of baseline	24 hours Post operative