Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT03693638

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to compare haemodynamic changes, total dose of ephedrin requirement, and level of sensory blockade between fractionated dose and single dose spinal anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent Caesarean section

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Induced Hypertension	Drug: Bupivacaine-fentanyl Drug: Bupivacaine-fentanyl	N/A

Detailed Description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; single dose (SD) and fractionated dose (FD). All subjects will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After IV cannulas (18 - 20 G) were properly placed, premedication with intravenous (IV) ranitidine 50 mg and metoclopramide 10 mg were given. Additional IV access was added if MgSO4 must been continuously administered intravenously perioperatively. Standard monitor device were placed after patients had been transferred to operating room. Additional premedication such as intravenous midazolam 0.02 mg/BW or fentanyl 1 mcg/BW were given if the patients were anxious or in pain. Baseline haemodynamic measurement was done two minutes after premedication. Spinal anesthesia was performed while patients in sitting position at L3-4 or L4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After skin wheal of lidocaine at the intended spinous interspace were placed, spinal needle (SpinocanR, B Braun, 27 G) were inserted and advanced until subarachnoid space were reached. In group FD, 1,5 ml of total dose followed by 1 ml remaining dose after 90 s interval were given. In SD group, 2,5 ml total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds. If there were more than three injection attempts, the patients were excluded from the study. Co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Comparative Study of Fractionated Vs Single Dose Injection for Spinal Anesthesia During Caesarean Section in Patients With Pregnancy-Induced Hypertension

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single dose (SD) 2,5 ml total anesthetic drug dose (Bupivacaine-fentanyl) were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds	Drug: Bupivacaine-fentanyl 2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds
Active Comparator: Fractionated dose (FD) 1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given	Drug: Bupivacaine-fentanyl 1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given

Arm

Intervention/Treatment

Active Comparator: Single dose (SD)

2,5 ml total anesthetic drug dose (Bupivacaine-fentanyl) were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds

Drug: Bupivacaine-fentanyl

2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds

Active Comparator: Fractionated dose (FD)

1,5 ml of total anesthetic drug dose (Bupivacaine-fentanyl) followed by 1 ml remaining dose after 90 s interval were given

Drug: Bupivacaine-fentanyl

1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given

Outcome Measures

Primary Outcome Measures

Change of mean arterial pressure (MAP) [15 minutes]
drop of blood pressure more than 20% of baseline value, and were treated with ephedrine 5 - 10 mg which could be repeated if necessary

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

with hypertension in pregnancy (gestational hypertension or preeclampsia)
ASA II-III
aged 18 - 40 years
BMI 18.5 - 35 kg/m2
singleton pregnancy
would undergo spinal anesthesia for emergency or semi-emergency caesarean section