Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering

NCT03675555 | Completed Phase 4

• 1 other identifier: R 47 / 2018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Shivering

Outcome Measures

Primary Outcomes (1)

• The incidence of clinically significant PSAS which required IV pethidine for treatment (Grade 2 (moderate) and Grade 3 (severe))

  The incidence of clinically significant PSAS which required IV pethidine for treatment (Grade 2 (moderate) and Grade 3 (severe)) after the first 90 min (end point of the study) after the completion of the subarachnoid drug injection (start point of the study).

  The first 90 min (end point of the study) after the completion of the subarachnoid drug injection (start point of the study).

Study Arms (3)

M (Mirtazapine) (Merta) group:(n=100)

ACTIVE COMPARATOR

Drug: Mirtazapine

D (Dexamethasone) (Dex) group: (n=100)

ACTIVE COMPARATOR

Drug: Dexamethasone phosphate

C (Control) group: (n=100)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mirtazapine DRUG

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.

Also known as: Remeron

M (Mirtazapine) (Merta) group:(n=100)

Dexamethasone phosphate DRUG

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.

D (Dexamethasone) (Dex) group: (n=100)

Placebo DRUG

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.

C (Control) group: (n=100)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• 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
• and underwent gynecological 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

Related Publications (1)

• Esmat IM, Elsayed AM, El-Hariri HM, Ashoor TM. A Randomized Controlled Trial for Prevention of Postspinal Anesthesia Shivering in Gynecological Surgeries: Mirtazapine vs. Dexamethasone. Anesthesiol Res Pract. 2022 Mar 9;2022:5061803. doi: 10.1155/2022/5061803. eCollection 2022.

  PMID: 35310422 DERIVED

MeSH Terms

Interventions

Mirtazapine; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 18, 2018
• Study Start: March 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

EG (1)