Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation

NCT04617652 | Completed Phase 4

• 1 other identifier: R142
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal extubation is a critical event in the anaesthetic management of patients undergoing general anaesthesia with endotracheal intubation for elective procedures. It the state of art to provide suitable conditions for smooth extubation and avoid coughing, bucking, straining and/or laryngospasm. Several methods have been described to provide a smooth extubation, including the use of remifentanil infusion, dexmedetomidine or fentanyl. Because of its anti-inflammatory and analgesic effects and lack of respiratory depressant actions, magnesium sulphate could be an attractive alternative.

Conditions

Smooth Extubation

Keywords

Magnesium Sulphate; General Anesthesia; Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

• smoothness of extubation

  Smoothness of extubation Grade 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm

  Procedure (At time of extubation)

Secondary Outcomes (27)

• sedation score

  1 hrs after extubation

• sedation score

  1 hour after extubation

• heart rate

  5 minutes before induction of anathesia

• Mean arterial blood pressure

  5 minutes before induction of anathesia

• SpO2

  5 minutes before induction of anathesia

Study Arms (2)

Group M

ACTIVE COMPARATOR

Magnesium group

Drug: Magnesium sulfate

Group C

PLACEBO COMPARATOR

Control group

Drug: Normal saline

Interventions

Magnesium sulfate DRUG

Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.

Also known as: Magnesium Group

Group M

Normal saline DRUG

Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.

Also known as: Placebo Group

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgeries that need endotracheal intubation.
• Duration of surgery 1-3 hours
• ASA Ⅰ-Ⅱ

You may not qualify if:

• Refusal of patients.
• Patients with hypersensitivity to the study drug.
• Patients with cardiac disorders, bundle branch block, hart block
• Neuromuscular disease, calcium channel blocker medication or hypermagnesemia

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Atef S Khalil, MD

  Fayoum University Hospitals

  PRINCIPAL INVESTIGATOR

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: Principal investigator

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 5, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

EG (1)