Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05892705

Collaborator

(none)

Enrollment

Location

Arms

19.5

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Intrathecal Dexmedetomidine	Drug: Dexmedetomidine Injection [Precedex]	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jan 15, 2023

Actual Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study drug (dexmedetomidine intrathecal) 5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.	Drug: Dexmedetomidine Injection [Precedex] intrathecal injection of 5 mcg dexmedetomidine
Placebo Comparator: Control (saline) 0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.	Drug: Dexmedetomidine Injection [Precedex] intrathecal injection of 5 mcg dexmedetomidine

Arm

Intervention/Treatment

Active Comparator: Study drug (dexmedetomidine intrathecal)

5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Drug: Dexmedetomidine Injection [Precedex]

intrathecal injection of 5 mcg dexmedetomidine

Placebo Comparator: Control (saline)

0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Drug: Dexmedetomidine Injection [Precedex]

intrathecal injection of 5 mcg dexmedetomidine

Outcome Measures

Primary Outcome Measures

Effect of subarachnoid dexmedetomidine on hemodynamic parameters. [Two hours]
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. [Six hours]
Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abbasia	Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaimaa Mohamed Samir Ezzat Rakhia, MD, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05892705

Other Study ID Numbers:

FAMSU R 120 / 2021

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vomiting

Postoperative Nausea and Vomiting

Dexmedetomidine

Study Results

No Results Posted as of Jun 7, 2023