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Completed

NCT Number: NCT04095013

Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital Karachi, Karachi, Sindh, Pakistan

Loading trial locations.

About this study

The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Term pregnancy Singleton ASA I and II, BMI <35, elective C/section

Exclusion criteria

patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Treatment and study plan

Bupivacaine, fentanyl

Drug

Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,

Bupivacaine, dexmedetomidine

Drug

Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

Primary outcomes

  1. Time till T10 dermatome achieved (Sec)

    Time frame: Post operative initial hour

    Spinal block characteristics

  2. Time of maximum bromage achieved (Sec)

    Time frame: Post operative initial hour

    Spinal block characteristics

  3. Regression time to T10 dermatome (Min)

    Time frame: Post operative initial hour

    Spinal block characteristics

  4. Time of complete motor recovery (Min)

    Time frame: Post operative initial hour

    Spinal block characteristics

  5. Post-operative pain score

    Time frame: 1 hour

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

  6. Post-operative pain score

    Time frame: 2 hour

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

  7. Post-operative pain score

    Time frame: 3 hour

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

  8. Post-operative pain score

    Time frame: 4 hour

    VAS score indicate 0 no pain 10 severe pain. Pain score was noted down

Secondary outcomes

  1. Nausea

    Time frame: 24 hours Post operative

    Sensation to throw out stomach contents

  2. Vomiting

    Time frame: 24 hours Post operative

    Act of throwing out stomach contents through mouth

  3. Pruritus

    Time frame: 24 hours Post operative

    Unpleasing sensation on the skin that provokes to scratch

  4. Respiratory distress

    Time frame: 24 hours Post operative

    Difficulty in breathing

  5. Shivering

    Time frame: 24 hours Post operative

    The act of shaking slightly and uncomfortably due to felling of cold temperature

  6. Bradycardia

    Time frame: 24 hours Post operative

    Heat rate less than <60 bpm

  7. Hypotension

    Time frame: 24 hours Post operative

    Decrease in BP greater than 20% of baseline

Other outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline

    Hemodynamics

  2. Systolic Blood Pressure

    Time frame: Immediate after giving intrathecal injection and positoning

    Hemodynamics

  3. Systolic Blood Pressure

    Time frame: at 5 minute

    Hemodynamics

  4. SBP

    Time frame: at 10 minute

    Hemodynamics

  5. Systolic Blood Pressure

    Time frame: at 15 minute

    Hemodynamics

  6. Systolic Blood Pressure

    Time frame: at 20 minute

    Hemodynamics

  7. Diastolic Blood Pressure

    Time frame: Baseline

    Hemodynamics

  8. Diastolic Blood Pressure

    Time frame: Immediate after giving intrathecal injection and positoning

    Hemodynamics

  9. Diastolic Blood Pressure

    Time frame: at 5 minute

    Hemodynamics

  10. Diastolic Blood Pressure

    Time frame: at 10 minute

    Hemodynamics

  11. Diastolic Blood Pressure

    Time frame: at 15 minute

    Hemodynamics

  12. Diastolic Blood Pressure

    Time frame: at 20 minute

    Hemodynamics

  13. Heart Rate

    Time frame: Baseline

    Hemodynamics

  14. Heart Rate

    Time frame: Immediate after giving intrathecal injection and positoning

    Hemodynamics

  15. Heart Rate

    Time frame: at 5 minute

    Hemodynamics

  16. Heart Rate

    Time frame: at 10 minute

    Hemodynamics

  17. Heart Rate

    Time frame: at 15 minute

    Hemodynamics

  18. Heart Rate

    Time frame: at 20 minute

    Hemodynamics

  19. oxygen saturation

    Time frame: Baseline

    Hemodynamics

  20. oxygen saturation

    Time frame: Immediate after giving intrathecal injection and positoning

    Hemodynamics

  21. oxygen saturation

    Time frame: at 5 minute

    Hemodynamics

  22. oxygen saturation

    Time frame: at 10 minute

    Hemodynamics

  23. oxygen saturation

    Time frame: at 15 minute

    Hemodynamics

  24. oxygen saturation

    Time frame: at 20 minute

    Hemodynamics

  25. respiratory rate

    Time frame: Baseline

    Hemodynamics

  26. respiratory rate

    Time frame: Immediate after giving intrathecal injection and positoning

    Hemodynamics

  27. respiratory rate

    Time frame: at 5 minute

    Hemodynamics

  28. respiratory rate

    Time frame: at 10 minute

    Hemodynamics

  29. respiratory rate

    Time frame: at 15 minute

    Hemodynamics

  30. respiratory rate

    Time frame: at 20 minute

    Hemodynamics

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2019
Registry last updated
Sep 19, 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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