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Completed

NCT Number: NCT03775655

Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.

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Key information

Conditions

Cesarean Section Dexmedetomidine Spinal Anesthesia

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Full-term pregnant women
  • Singleton gestation
  • American Society of Anaesthesiologists (ASA) physical status classes II and I

Exclusion criteria

  • Preterm pregnancy (<37 wks. gestation)
  • Multiple gestation
  • Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
  • Asthma and allergy to non-steroidal anti-inflammatory drugs
  • Conditions that prevent spinal anaesthesia
  • Failed spinal block and conversion to general anaesthesia
  • A history of established chronic pain
  • Drug addiction
  • A psychiatric disorder
  • Inability to communicate effectively

Treatment and study plan

Dexmedetomidine

Drug

10μg dexmedetomidine will be added to the injectate to be injected intrathecally

Other names: Precedex

Primary outcomes

  1. Density of motor and sensory blockade

    Time frame: Intraoperative

  2. Haemodynamic stability and total doses of IV fluids and vasopressors

    Time frame: Intraoperative

  3. Time to first postoperative rescue analgesic request

    Time frame: 24 hour

Secondary outcomes

  1. The intraoperative patient and surgeon satisfaction (successful delivery)

    Time frame: Intraoperative

  2. The peak sensory level of block

    Time frame: Intraoperative

  3. Time from intrathecal injection to peak sensory block level

    Time frame: Intraoperative

  4. The time to two sensory block segment regression

    Time frame: Intraoperative and 24 hour

  5. Degree and duration of motor block

    Time frame: Intraoperative and 24 hour

  6. Intraoperative analgesic supplementation during operation

    Time frame: Intraoperative

  7. Postoperative pain scores for 24 hours

    Time frame: 24 hour

  8. Frequency and total dose of postoperative analgesics

    Time frame: 24 hour

  9. Intraoperative and postoperative sedation scores

    Time frame: Intraoperative and 24 hour

  10. Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.

    Time frame: Intraoperative and 24 hour

  11. Hospital in stay

    Time frame: 24 hour

  12. Time to S1 level sensory regression

    Time frame: Intraoperative and 24 hour

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Jan 15, 2019

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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