Smooth Extubation With Magnesium Sulphate for General Anesthesia With Endotracheal Intubation

Efficacy of Magnesium Sulphate on Smoothness of Extubation in Patients Undergoing General Anaesthesia With Endotracheal Intubation: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Smooth Extubation
• Intervention / Treatment: Drug: Magnesium sulfate; Drug: Normal saline

Detailed Description

A written informed consent will be obtained from all the patients. On arrival to the preparation room intravenous cannula will be inserted, no sedation will be given. In the operating theater standard monitors, non-invasive blood pressure, oxygen saturation and electrocardiogram will be applied before induction of anesthesia, capnography after induction of anesthesia and baseline heart rate (HR), mean arterial blood pressure (MAP) and oxygen saturation (SpO2 ) will be recorded.

All patients in both groups will receive standardized anesthetic technique in the form of intravenous (i.v.) propofol 2 mg/kg, i.v. fentanyl 1-2 lg/kg and atracurium 0.5 mg/kg to facilitate endo-tracheal intubation, mechanical ventilation will be adjusted to keep end tidal carbon dioxide (EtCO2) between 30 and 35 mmHg, and all drugs will be based on ideal body weight. Isoflurane 1% in 50% oxygen and air, and 0.15 mg/kg atracurium every 20 min will be given for maintenance of anesthesia. Intraoperative HR, MAP, EtCO2 and SpO2 values will be recorded at 5- minute intervals till the end of operation. HR and MAP will be maintained within ±20% of the baseline values. Hypotension (defined as MAP < 20% of the baseline value) will be treated by a bolus of 200 ml Ringer's solution if not responding increments of 3-9 mg ephedrine will be given. Hypertension (defined as MAP > 20% of the baseline value) and/or tachycardia (defined as HR > 20% of the baseline value) a supplemental dose (25-50 µg) fentanyl will be given or increasing concentration of isoflurane. Bradycardia (HR < 50 beat per minute) persisting for >2 min will be treated with atropine, 0.4 mg i.v. boluses. Intra-operatively i.v. ondansetron, 4 mg (Zofran, GlaxoSmithKline) will be given for prevention of postoperative nausea and vomiting. After induction of anaesthesia patients will be divided into 2 groups: group C (control group) n= 30 patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour. Group M (magnesium group n=30 patients) will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.

By the end of surgery isoflurane will be discontinued and the residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg, given with atropine 0.02 mg/kg, the endotracheal tube will be removed after return of spontaneous breathing, and the patient will obey commands in semi-sitting position, then the patient will be transferred to the post-anesthesia care unit (PACU)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt
    • Fayoum, Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, Egypt, 63514
      • Fayoum University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group M; Magnesium group	Drug: Magnesium sulfate; Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.; Other Names: Magnesium Group
Placebo Comparator: Group C; Control group	Drug: Normal saline; Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.; Other Names: Placebo Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoothness of extubation	Smoothness of extubation Grade; No coughing on endotracheal tube; Coughing on the tube; Vomiting; Laryngospasm	Procedure (At time of extubation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation score	Ramsey sedation score (RSS): 1 - Anxious, agitated or restless; 2 - Cooperative and oriented; 3 - Responsive to commands; 4 - Asleep, but response to light glabellar tap or loud auditory; 5 - Asleep, sluggish response to glabellar tab or auditory response; and 6 - Asleep, no response	1 hrs after extubation
sedation score	Ramsey sedation score (RSS): 1 - Anxious, agitated or restless; 2 - Cooperative and oriented; 3 - Responsive to commands; 4 - Asleep, but response to light glabellar tap or loud auditory; 5 - Asleep, sluggish response to glabellar tab or auditory response; and 6 - Asleep, no response	1 hour after extubation
heart rate	hemodynamic parameters	5 minutes before induction of anathesia
Mean arterial blood pressure	hemodynamic parameters	5 minutes before induction of anathesia
SpO2	hemodynamic parameters	5 minutes before induction of anathesia
EtCO2	hemodynamic parameters	5 minutes before induction of anathesia
heart rate	hemodynamic parameters	5 minutes after induction of anathesia
Mean arterial blood pressure	hemodynamic parameters	5 minutes after induction of anathesia
SpO2	hemodynamic parameters	5 minutes after induction of anathesia
EtCO2	hemodynamic parameters	5 minutes after induction of anathesia
heart rate	hemodynamic parameters	10 minutes after induction of anathesia
Mean arterial blood pressure	hemodynamic parameters	10 minutes after induction of anathesia
SpO2	hemodynamic parameters	10 minutes after induction of anathesia
EtCO2	hemodynamic parameters	10 minutes after induction of anathesia
heart rate	hemodynamic parameters	15 minutes after induction of anathesia
Mean arterial blood pressure	hemodynamic parameters	15 minutes after induction of anathesia
SpO2	hemodynamic parameters	15 minutes after induction of anathesia
EtCO2	hemodynamic parameters	15 minutes after induction of anathesia
heart rate	hemodynamic parameters	20 minutes after induction of anathesia
Mean arterial blood pressure	hemodynamic parameters	20 minutes after induction of anathesia
SpO2	hemodynamic parameters	20 minutes after induction of anathesia
EtCO2	hemodynamic parameters	20 minutes after induction of anathesia
visual analogue scale (VAS) pain score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	4 hours after extubation
visual analogue scale (VAS) pain score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	6 hours after extubation
The duration of surgery	time needed to perform surgery	5 minutes after extubation
Intraoperative fentanyl needed	The amount of Fentanyl given intraoperative as fentanyl will be given when either heart rate or NIBP(Non-Invasive Blood Pressure) report an increase by more than 20% of the basal records	5 minutes after extubation
The cumulative opioids (morphine) consumption	The total amount of opioids received post operative	6 hours after surgery

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Atef S Khalil, MD, Fayoum University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: General Anesthesia; Magnesium Sulphate; Endotracheal Intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: R142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No