Clinical trial NCT04095013: Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
Official title: Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Elective low segment caesarean section
Intrathecal
bupivacaine-fentanyl
bupivacaine-dexmedetomidine
sensory block
complications
hemodynamics
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomize controlled trial (RCT)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time till T10 dermatome achieved (Sec)
timeFrame: Post operative initial hour
measure: Time of maximum bromage achieved (Sec)
timeFrame: Post operative initial hour
measure: Regression time to T10 dermatome (Min)
timeFrame: Post operative initial hour
measure: Time of complete motor recovery (Min)
timeFrame: Post operative initial hour
measure: Post-operative pain score
timeFrame: 1 hour
measure: Post-operative pain score
timeFrame: 2 hour
measure: Post-operative pain score
timeFrame: 3 hour
measure: Post-operative pain score
timeFrame: 4 hour
Secondary outcomes:
measure: Nausea
timeFrame: 24 hours Post operative
measure: Vomiting
timeFrame: 24 hours Post operative
measure: Pruritus
timeFrame: 24 hours Post operative
measure: Respiratory distress
timeFrame: 24 hours Post operative
measure: Shivering
timeFrame: 24 hours Post operative
measure: Bradycardia
timeFrame: 24 hours Post operative
measure: Hypotension
timeFrame: 24 hours Post operative
Other outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: Immediate after giving intrathecal injection and positoning
measure: Systolic Blood Pressure
timeFrame: at 5 minute
measure: SBP
timeFrame: at 10 minute
measure: Systolic Blood Pressure
timeFrame: at 15 minute
measure: Systolic Blood Pressure
timeFrame: at 20 minute
measure: Diastolic Blood Pressure
timeFrame: Baseline
measure: Diastolic Blood Pressure
timeFrame: Immediate after giving intrathecal injection and positoning
measure: Diastolic Blood Pressure
timeFrame: at 5 minute
measure: Diastolic Blood Pressure
timeFrame: at 10 minute
measure: Diastolic Blood Pressure
timeFrame: at 15 minute
measure: Diastolic Blood Pressure
timeFrame: at 20 minute
measure: Heart Rate
timeFrame: Baseline
measure: Heart Rate
timeFrame: Immediate after giving intrathecal injection and positoning
measure: Heart Rate
timeFrame: at 5 minute
measure: Heart Rate
timeFrame: at 10 minute
measure: Heart Rate
timeFrame: at 15 minute
measure: Heart Rate
timeFrame: at 20 minute
measure: oxygen saturation
timeFrame: Baseline
measure: oxygen saturation
timeFrame: Immediate after giving intrathecal injection and positoning
measure: oxygen saturation
timeFrame: at 5 minute
measure: oxygen saturation
timeFrame: at 10 minute
measure: oxygen saturation
timeFrame: at 15 minute
measure: oxygen saturation
timeFrame: at 20 minute
measure: respiratory rate
timeFrame: Baseline
measure: respiratory rate
timeFrame: Immediate after giving intrathecal injection and positoning
measure: respiratory rate
timeFrame: at 5 minute
measure: respiratory rate
timeFrame: at 10 minute
measure: respiratory rate
timeFrame: at 15 minute
measure: respiratory rate
timeFrame: at 20 minute
Locations:
city: Karachi
country: Pakistan
facility: Civil Hospital Karachi
state: Sindh
city: Karachi
country: Pakistan
facility: DUHS, Civil hospital Karachi (CHK)
state: Sindh
Study officials:
References: