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Trial record 75 of 325 for:    clonidine

Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering

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ClinicalTrials.gov Identifier: NCT03679052
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Brief Summary:
This study was conducted to study the effect of a prophylactic dose of oral mirtazapine on shivering compared with a prophylactic dose of oral clonidine in patients undergoing urological surgeries under spinal anesthesia.

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

  Show Detailed Description

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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 Clonidine for Post-spinal Anesthesia Shivering in Patients Undergoing Urological 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: Group I (Mirtazapine group): (n=100) Drug: Mirtazapine
Each patient received 30 mg mirtazapine tablet and a placebo tablet for clonidine orally with sips of water 2 h preoperatively.
Other Name: Remeron

Active Comparator: Group II (Clonidine group): (n=100) Drug: Clonidine
Each patient received 150 µg clonidine tablet and a placebo tablet for mirtazapine orally with sips of water 2 h preoperatively.
Other Name: Catapress

Placebo Comparator: Group III (Control group): (n=100) Drug: Placebo
Each patient received two placebo tablets for mirtazapine and clonidine orally with sips of water 2 h 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)



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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
    • underwent urological 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): NCT03679052


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, M.D., Department of Anesthesia and Intensive Care, Ain- shams University, Egypt., Ain Shams University
ClinicalTrials.gov Identifier: NCT03679052     History of Changes
Other Study ID Numbers: R 48 / 2018
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 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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Clonidine
Mirtazapine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Anxiety Agents
Tranquilizing Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists