Effect of Intranasal Dexmedetomidine or Oral Midazolam Premedication on the Minimum Alveolar Concentration of Sevoflurane for the Insertion of Laryngeal Mask Airway in children.

Phase 3

Completed

• Conditions: Any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion

• Registration Number: CTRI/2013/02/003438
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

The study was planned to evaluate andcompare the effect of   intranasal dexmedetomidine or oral midazolam onthe EC50 requirement of sevoflurane for LMA insertion in childrencompared to placebo.  56 ASA 1children (1-6yrs) scheduled for general anaesthesia with LMA were randomly allocated tothree groups: group M received 0.5 mg/Kg oral midazolam and intranasal saline, groupD received 2µg/Kg  intranasaldexmedetomidine along with oral honey, and  group P received oral honey and intranasalsaline 30min before procedure. Anesthesia was induced with sevoflurane.Apredetermined target end-tidal sevoflurae concentration (starting at 2%) was maintained for 10 min using Dixon’sup-down method and the laryngeal mask airway was inserted without neuromuscularblockade. The target end-tidal concentration in the next patient was increasedor decreased by 0.2% depending upon the response of the previous patient.Insertion of the laryngeal mask airway without coughing, clenching, biting,movement or any adverse airway event during or within 1 min after insertion wasconsidered to be successful.in case of success the ET sevoflurane concentartion was decreased by 0.2% otherwise it was increased by 0.2%. All responses to an LMA insertion wereassessed with the LMA insertion score.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-23
• Last Update Posted: 2013-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

ASA 1 and 2 patients of either gender of the age 1- 6 years undergoing any short elective surgical procedure under general anaesthesia which can be performed with LMA insertion.

Exclusion Criteria

airway malformations, clinical evidence of patients with difficult airway, asthma or any sign of upper respiratory tract infection, G6PD deficiency, organ dysfunction , allergy or hypersensitive reaction to dexmedetomidine , known cardiac arrhythmia or congenital heart disease, mentally disabled , known case of autism or developmental pervasive disorder or failure to insert LMA.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine and compare the EC50 of sevoflurane for LMA insertion in children in all the three groups	At or one minute after LMA insertion

Secondary Outcome Measures

Name	Time	Method
Ramsay Sedation Score, parental separation score, induction score success rate, and the incidence of adverse events	Ramsay sedation score at baseline, 15 and 30 minutes after premedication, parental separation score at taking the child in the OT and induction score at placing the face mask, adverse events at or one minute after LMA insretion

Trial Locations

Locations (1)

PGIMER, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Babita Ghai

Principal investigator

9914209533

ghaibabita@hotmail.com