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spinal anaeathesia for caesarean section using drug in fixed dosed or based on height and weight

A comparative evaluation Spinal block characteristics using fixed dose versus height and weight adjusted dose of intrathecal bupivacainen and fentanyl for patient under going elective caesarean section - A double blind randomised comparative evaluation of fixed dose versus height and weight dose of intrathecal hyperbaric bupivacaine and fentanyl for elective caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008348
Enrollment
200
Registered
2017-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA 1&2

Interventions

Intervention1: Group FD: Patients received fixed dose of 2 ml of 0.5% Bupivacaine (10 mg) and 0.2 ml of Fentanyl Control Intervention1: Group AD: Patient received height and weight adjusted doses of H

Sponsors

VMMC Safdarjang Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA status 1 & 2 2.Patients scheduled to undergo elective caesarean surgery. 3.Adult female patients with weight between 50 to 110 kg and height from 140 cm to 180 cm. 4.Singleton pregnancy

Exclusion criteria

Exclusion criteria: • Inability of the patients to understand the procedure. • Contraindications to Anaesthetic technique like patientâ??s refusal, local infection, coagulation abnormalities, history of allergic reaction to any of the drug to be used, sepsis, shock, spinal deformities, previous spinal surgeries, neurological disturbances, cardiac failure. • Complicated pregnancies, Pre-ecclampsia, Pregnancy Induced Hypertension. • Patients with acute fetal distress

Design outcomes

Primary

MeasureTime frame
1 Maximum upper level of sensory block reached and time required achieving this. â?¢ Maximum degree of motor block and time required to achieve this (complete motor block). â?¢ Total duration of motor block (from initial onset until complete recovery). â?¢ Supplemental analgesia â?? Yes/No between height and adjusted doses and fixed doses of bupivacaine Timepoint: Time of giving spinal anaesthesia 0 Time for the level to reach T5 TT5 Time of Skin Incision TSI Time of Uterine Incision TUI Time of Delivery TD Time of Completion of Surgery TC Time to 2 Segment Regression TSR2 Time of First Rescue Analgesic given TFRA Maximum level of sensory block achieved Smax Maximum level of motor block achieved (Mmax) Mmax

Secondary

MeasureTime frame
1.Hypotension .Minimum Systolic blood pressure 88mmHg in FD group, 100 in Ad group.Timepoint: 1min till 15minutes than 5 mts;2. Bradycardia . Minimum heart rate was 58 /minTimepoint: 1 min till 15 mts and than 5 mts till end of surgery;nausea: 13 %Timepoint: nil;Neonatal AssessmentTimepoint: 1and 5 min;shivering: 34%Timepoint: nil;vomiting 4%Timepoint: nil

Countries

India

Contacts

Public ContactDr Poonam gupta

Vardhman Mahavir Medical College and safadarjang Hospital New Delhi

p.gupta182@gmail.com9818623450

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026