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Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering

NCT03675555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-12-21

No results posted yet for this study

Summary

This study was conducted to evaluate the effect of a prophylactic dose of oral mirtazapine on shivering compared with prophylactic intravenous infusion (IVI) dexamethasone in patients undergoing gynecological surgeries under spinal anesthesia.

Conditions

  • Shivering

Interventions

DRUG

Mirtazapine

Each patient received 30 mg Mirta tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline \[NS\]) (IVI) over 15 minutes as a placebo for Dex solution 2 hours preoperatively.

DRUG

Dexamethasone phosphate

Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 minutes, 2 hours preoperatively.

DRUG

Placebo

Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minutes as a placebo for Dex solution 2 h preoperatively.preoperatively.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03675555 on ClinicalTrials.gov