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Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675555
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Brief 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.

Condition or disease Intervention/treatment Phase
Shivering Drug: Mirtazapine Drug: Dexamethasone phosphate Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering in Patients Undergoing Gynecological Surgeries: a Randomized Controlled Trial
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: M (Mirtazapine) (Merta) group:(n=100) 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.
Other Name: Remeron

Active Comparator: D (Dexamethasone) (Dex) group: (n=100) 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.

Placebo Comparator: C (Control) group: (n=100) 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.




Primary Outcome Measures :
  1. Total participants received pethidine for treatment of post-spinal shivering in the three groups till 20 minutes after the end of the procedure (in the recovery room) [ Time Frame: till 20 minutes after the end of the procedure (in the recovery room) ]
    Total participants received pethidine for treatment of post-spinal shivering in the three groups till 20 minutes after the end of the procedure (in the recovery room)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • on 300 patients aged 18-60 years
  • of the American Society of Anesthesiologists (ASA) physical status I or II
  • and underwent gynecological surgeries under spinal anesthesia.
  • A written informed consent was obtained from all patients to participate in the study.

Exclusion Criteria:

  • Patient`s refusal,
  • duration of surgery more than 120 min,
  • obesity with body mass index (BMI) >35 kg/m2,
  • generalized infection or localized infection at level of blockade,
  • neurologic disease,
  • coagulation disorder,
  • patients with hypo- or hyperthyroidism,
  • cardiopulmonary disease,
  • psychological disorders,
  • a need for blood transfusion during surgery,
  • an initial body temperature >38.0C or <36.0C,
  • a known history of alcohol or substance abuse,
  • or receiving vasodilators, or medications likely to alter thermoregulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675555


Locations
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Egypt
Ibrahim Mamdouh Esmat
Heliopolis, Cairo, Egypt, 11361
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University
ClinicalTrials.gov Identifier: NCT03675555    
Other Study ID Numbers: R 47 / 2018
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Mirtazapine
Dexamethasone 21-phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists