Magnesium Sulphate and Sevoflurane Induced Emergence Agitation in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
anesthesia department
faculty of medicine
Information provided by (Responsible Party):
Abeer Ahmed, Cairo University
ClinicalTrials.gov Identifier:
NCT01743144
First received: November 18, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

Rationale:

Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis, in which rapid recovery with safe airway after extubation is crucial. Sevoflurane is considered the inhaled anesthetic of choice in such procedures, however it has been reported that emergence agitation (EA) is a frequent complication in 30-80% of children receiving sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the incidence of EA in children was not adequately investigated.

Objective:

To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4) infusion on the incidence of sevoflurane-induced EA in children undergoing adenotonsillectomy.

Study population and sample size:

Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance difference of 40% in the incidence of agitation between two groups, with a power of 80% and alpha error of 5%.

Study design:

A double blind, randomized, placebo controlled study.

Method:

In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end of surgery. Post operative emergence agitation will be assessed by using the Pediatric Anesthesia Emergence Delirium scale.

Possible risks:

Drug side effects such as facial warmth, flushing, dry mouth, and malaise.

Outcome parameters:

The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative complications

Statistical analysis plan:

Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as appropriate. The possible relationship between EA and pain scores will be evaluated with the use of Spearman's rank correlation coefficient

Time plan:

6-9 months.


Condition Intervention Phase
Emergence Delirium
Postopertive Delirium
Emergence Agitation in Children
Drug: Magnesium Sulfate
Drug: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Study the Possible Effects of Intraoperative Intravenous Magnesium Sulphate Infusion on the Incidence of Sevoflurane Induced Emergence Agitation in Children Undergoing Adenotonsillectomy

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • change from baseline of sevoflurane induced emergence agitation(EA) at 2 hours postoperative by using Pediatric Anesthesia Emergence Delirium (PEAD) score [ Time Frame: on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative pain which is going to be assessed by the well established behavior pain scale "Children's Hospital Eastern Ontario Scale" (CHEOPS) [ Time Frame: on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • post operative rescue analgesic requirements, perioperative hemodynamic variables, durations of recovery, hospital stay and postoperative complications (vomiting, laryngospasm, bronchospasm, or bleeding from surgical site). [ Time Frame: for 2 hours postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium sulphate
Magnesium sulphate (MgSO4) 10% solution is going to be used, an initial MgSO4 bolus dose 30mg/kg (i.e. 0.3mL/kg) will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous infusion of 10 mg/kg/hr (i.e. 0.1 ml/kg/h). Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
Drug: Magnesium Sulfate
Magnesium sulphate (MgSO4) 10% solution is going to be used, an initial MgSO4 bolus dose 30mg/kg (i.e. 0.3mL/kg) will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous infusion of 10 mg/kg/hr (i.e. 0.1 ml/kg/h). Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
Placebo Comparator: normal saline
normal saline (NaCl 9%) is going to be used, an initial normal saline bolus dose 0.3ml/kg will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous normal saline infusion of 0.1 ml/kg/h. Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
Drug: normal saline
normal saline (NaCl 9%) is going to be used, an initial normal saline bolus dose 0.3ml/kg will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous normal saline infusion of 0.1 ml/kg/h. Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included in the study.

Exclusion Criteria:

  • The study will exclude children with behavioral changes, physical developmental delay and children on treatment with sedative or anticonvulsant. Also children with pre-existing renal disease or cardiovascular diseases will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743144

Locations
Egypt
Anesthesia department - Faculty of medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
anesthesia department
faculty of medicine
Investigators
Study Chair: Mohamed Abdulatif, Anesthesia Professor Anesthesia department-Faculty of medicine-Cairo University
  More Information

No publications provided

Responsible Party: Abeer Ahmed, lecturer of anesthesia, faculty of medicine, cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT01743144     History of Changes
Other Study ID Numbers: N-40-2012
Study First Received: November 18, 2012
Last Updated: February 13, 2013
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Cairo University:
emergence agitation in children
sevoflurane
general anesthesia
magnesium sulphate

Additional relevant MeSH terms:
Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders
Magnesium Sulfate
Sevoflurane
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 28, 2014