Back to resultsIntrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
Primary Purpose
Intrathecal Dexmedetomidine
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine Injection [Precedex]
Sponsored by
About this trial
This is an interventional prevention trial for Intrathecal Dexmedetomidine
Eligibility Criteria
Inclusion Criteria: Medically free pregnant Female from 18 to 30 yrs old. Undergoing elective LSCS. Body mass index less than 40. Consenting for sub arachnoid anesthesia. Coagulation profile is within normal ranges. Exclusion Criteria: Emergency LSCS. Patient refusal enrollment in the study. Allergy to the medications. Coagulopathy or anticoagulation drugs. Fetal or Maternal comorbidities.
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Study drug (dexmedetomidine intrathecal)
Control (saline)
Arm Description
5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Outcomes
Primary Outcome Measures
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
Measure heart rate, blood pressure, temperature, oxygen saturation
Secondary Outcome Measures
Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.
Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05892705
Brief Title
Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
Official Title
Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrathecal Dexmedetomidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study drug (dexmedetomidine intrathecal)
Arm Type
Active Comparator
Arm Description
5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Arm Title
Control (saline)
Arm Type
Placebo Comparator
Arm Description
0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection [Precedex]
Intervention Description
intrathecal injection of 5 mcg dexmedetomidine
Primary Outcome Measure Information:
Title
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
Description
Measure heart rate, blood pressure, temperature, oxygen saturation
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.
Description
Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.
Time Frame
Six hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medically free pregnant Female from 18 to 30 yrs old.
Undergoing elective LSCS.
Body mass index less than 40.
Consenting for sub arachnoid anesthesia.
Coagulation profile is within normal ranges.
Exclusion Criteria:
Emergency LSCS.
Patient refusal enrollment in the study.
Allergy to the medications.
Coagulopathy or anticoagulation drugs.
Fetal or Maternal comorbidities.
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbasia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.
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