Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering

NCT03679052 | Completed Phase 4

• 1 other identifier: R 48 / 2018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Shivering

Outcome Measures

Primary Outcomes (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)

  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)

  till 20 minutes after the end of the procedure (in the recovery room)

Study Arms (3)

Group I (Mirtazapine group): (n=100)

ACTIVE COMPARATOR

Drug: Mirtazapine

Group II (Clonidine group): (n=100)

ACTIVE COMPARATOR

Drug: Clonidine

Group III (Control group): (n=100)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mirtazapine DRUG

Each patient received 30 mg mirtazapine tablet and a placebo tablet for clonidine orally with sips of water 2 h preoperatively.

Also known as: Remeron

Group I (Mirtazapine group): (n=100)

Clonidine DRUG

Each patient received 150 µg clonidine tablet and a placebo tablet for mirtazapine orally with sips of water 2 h preoperatively.

Also known as: Catapress

Group II (Clonidine group): (n=100)

Placebo DRUG

Each patient received two placebo tablets for mirtazapine and clonidine orally with sips of water 2 h preoperatively.

Group III (Control group): (n=100)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ibrahim Mamdouh Esmat

Heliopolis, Cairo Governorate, 11361, Egypt

Location

MeSH Terms

Interventions

Mirtazapine; Clonidine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, M.D., Department of Anesthesia and Intensive Care, Ain- shams University, Egypt.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

EG (1)