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NCT Number: NCT07416084

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

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

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Key information

Conditions

Hypotension After Spinal Anesthesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Liaquat National Hospital and Medical College

Karachi, Sindh, 75300, Pakistan

Location contact

Anum Fatima, MBBS

CONTACT

[email protected]

03341891863

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Maternal hypotension

    Time frame: Baseline

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

Secondary outcomes

  1. Maternal heart rate trend

    Time frame: Baseline

    Maternal heart rate as bpm

  2. Use of vasopressors

    Time frame: Baseline

    Requirement for vasopressors

  3. Nausea and vomiting

    Time frame: Baseline

    incidence of nausea/vomiting due to hypotension

  4. APGAR score

    Time frame: Baseline

    Fetal Apgar scores at 1 and 5 minutes

  5. Conversion to general anesthesia

    Time frame: Baseline

    Patients requiring general anesthesia after spinal anesthesia

  6. Maternal MAP trend

    Time frame: Baseline

    MAP as mm Hg

Study contacts

Contact information is provided by the study sponsor or research team.

Anum Fatima, MBBS

CONTACT

[email protected]

+923341891863

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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