Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
NCT ID: NCT05892705
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2021-06-01
2023-01-15
Brief Summary
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Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.
Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.
Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Study drug (dexmedetomidine intrathecal)
5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Dexmedetomidine Injection [Precedex]
intrathecal injection of 5 mcg dexmedetomidine
Control (saline)
0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Dexmedetomidine Injection [Precedex]
intrathecal injection of 5 mcg dexmedetomidine
Interventions
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Dexmedetomidine Injection [Precedex]
intrathecal injection of 5 mcg dexmedetomidine
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective LSCS.
* Body mass index less than 40.
* Consenting for sub arachnoid anesthesia.
* Coagulation profile is within normal ranges.
Exclusion Criteria
* Patient refusal enrollment in the study.
* Allergy to the medications.
* Coagulopathy or anticoagulation drugs.
* Fetal or Maternal comorbidities.
18 Years
30 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Shaimaa Mohamed Samir Ezzat Rakhia
MD
Locations
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Ain Shams University
Cairo, Abbasia, Egypt
Countries
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Other Identifiers
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FAMSU R 120 / 2021
Identifier Type: -
Identifier Source: org_study_id
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