Comparison of Hypotension After Spinal Anesthesia With Hyperbaric Vs Isobaric Bupivacaine in Elective Cesarean After Colloid Preloading.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLiaquat National Hospital & Medical College

About this trial

To assess the hemodynamic difference after spinal anesthesia with hyperbaric bupivacaine and isobaric bupivacaine in elective cesarean section

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA II parturient with normal pregnancy Parturients undergoing elective cesarean section under spinal anesthesia Parturient refusing normal trial of labor, planned for ELLSCS under spinal anesthesia

Disqualifiers

Patient refusal Parturient with known drug allergy to local anesthetics Parturients undergoing emergency cesarean section Spinal anesthesia converted to general anesthesia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal anesthesia with hyperbaric bupivacaine

    Drug

    Spinal anesthesia with hyperbaric bupivacaine according to height

  • Spinal anesthesia with isobaric bupivacaine

    Drug

    Spinal anesthesia with Isobaric bupivacaine according to height

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Hyperbaric bupivacaineActive comparator 1 intervention
Group B: Isobaric bupivacaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maternal hypotension

Incidence of maternal hypotension (MAP \< 60 mm Hg or drop in MAP \> 20% of the baseline) within 5 minutes after intrathecal drug administration

Time frame
Baseline

Secondary outcomes

1

Maternal heart rate trend

Maternal heart rate as bpm

Time frame
Baseline
2

Use of vasopressors

Requirement for vasopressors

Time frame
Baseline
3

Nausea and vomiting

incidence of nausea/vomiting due to hypotension

Time frame
Baseline
4

APGAR score

Fetal Apgar scores at 1 and 5 minutes

Time frame
Baseline

Other outcomes

Sponsors and contacts

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