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

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Bupivacaine, fentanyl; Drug: Bupivacaine, dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75520
      • Civil Hospital Karachi
    • Karachi, Sindh, Pakistan, 75520
      • DUHS, Civil hospital Karachi (CHK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group BF; hyperbaric Bupivacaine 10mg with fentanyl 10micrograms	Drug: Bupivacaine, fentanyl; Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
EXPERIMENTAL: Group BD; hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms	Drug: Bupivacaine, dexmedetomidine; Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time till T10 dermatome achieved (Sec)	Spinal block characteristics	Post operative initial hour
Time of maximum bromage achieved (Sec)	Spinal block characteristics	Post operative initial hour
Regression time to T10 dermatome (Min)	Spinal block characteristics	Post operative initial hour
Time of complete motor recovery (Min)	Spinal block characteristics	Post operative initial hour
Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	1 hour
Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	2 hour
Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	3 hour
Post-operative pain score	VAS score indicate 0 no pain 10 severe pain. Pain score was noted down	4 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	Sensation to throw out stomach contents	24 hours Post operative
Vomiting	Act of throwing out stomach contents through mouth	24 hours Post operative
Pruritus	Unpleasing sensation on the skin that provokes to scratch	24 hours Post operative
Respiratory distress	Difficulty in breathing	24 hours Post operative
Shivering	The act of shaking slightly and uncomfortably due to felling of cold temperature	24 hours Post operative
Bradycardia	Heat rate less than <60 bpm	24 hours Post operative
Hypotension	Decrease in BP greater than 20% of baseline	24 hours Post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Hemodynamics	Baseline
Systolic Blood Pressure	Hemodynamics	Immediate after giving intrathecal injection and positoning
Systolic Blood Pressure	Hemodynamics	at 5 minute
SBP	Hemodynamics	at 10 minute
Systolic Blood Pressure	Hemodynamics	at 15 minute
Systolic Blood Pressure	Hemodynamics	at 20 minute
Diastolic Blood Pressure	Hemodynamics	Baseline
Diastolic Blood Pressure	Hemodynamics	Immediate after giving intrathecal injection and positoning
Diastolic Blood Pressure	Hemodynamics	at 5 minute
Diastolic Blood Pressure	Hemodynamics	at 10 minute
Diastolic Blood Pressure	Hemodynamics	at 15 minute
Diastolic Blood Pressure	Hemodynamics	at 20 minute
Heart Rate	Hemodynamics	Baseline
Heart Rate	Hemodynamics	Immediate after giving intrathecal injection and positoning
Heart Rate	Hemodynamics	at 5 minute
Heart Rate	Hemodynamics	at 10 minute
Heart Rate	Hemodynamics	at 15 minute
Heart Rate	Hemodynamics	at 20 minute
oxygen saturation	Hemodynamics	Baseline
oxygen saturation	Hemodynamics	Immediate after giving intrathecal injection and positoning
oxygen saturation	Hemodynamics	at 5 minute
oxygen saturation	Hemodynamics	at 10 minute
oxygen saturation	Hemodynamics	at 15 minute
oxygen saturation	Hemodynamics	at 20 minute
respiratory rate	Hemodynamics	Baseline
respiratory rate	Hemodynamics	Immediate after giving intrathecal injection and positoning
respiratory rate	Hemodynamics	at 5 minute
respiratory rate	Hemodynamics	at 10 minute
respiratory rate	Hemodynamics	at 15 minute
respiratory rate	Hemodynamics	at 20 minute

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): June 15, 2019
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: September 14, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: complications; hemodynamics; Intrathecal; Elective low segment caesarean section; bupivacaine-fentanyl; bupivacaine-dexmedetomidine; sensory block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: dr.sanaurooj@yahoo.com

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No