Comparison of the Anaesthetic Gases in Maintainance of General Anaesthesia in Paediatrics

NCT04771962 | Completed Phase 1

• 1 other identifier: USM/JEPem/18050248
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Desflurane and Sevoflurane are one of the modern inhalational anaesthetic agents currently in use in anaesthetic practice. The properties of desflurane that has low blood gas solubility coefficient of 0.47 compared to sevoflurane (0.68) made it more advantageous when used with supraglottic airway in maintaining general anaesthesia in paediatrics . It ensures rapid onset and offset of anaesthesia. Rapid recovery profiles especially among pediatric populations is to ensure less complications associated with prolonged recovery of anaesthesia upon emergence from anaesthesia. Nevertherless, desflurane has its drawback which is it can cause airway irritability related to its pungency. Hence, it is not used as an induction anaesthetic agent in paediatrics. This study was done to evaluate the effectiveness of desflurane in comparison to sevoflurane in maintaining spontaneous general anaesthesia in paediatrics population using Ambu AuraGain .

Conditions

Paediatrics; General Anaesthesia

Keywords

paediatrics; spontaneous general anaesthesia

Outcome Measures

Primary Outcomes (3)

• To compare the blood pressure intraoperatively between desflurane and sevoflurane.

  by measuring the blood pressure

  up to 18 months

• To compare the heart rate intraoperatively between desflurane and sevoflurane.

  by measuring the heart rate

  up to 18 months

• To compare the mean arterial pressure intraoperatively between desflurane and sevoflurane.

  by measuring the mean arterial pressure

  up to 18 months

Secondary Outcomes (2)

• To compare the emergence time ( interval from gas being off to patient awake).

  up to 18 months

• To compare the respiratory events intraoperative and post operative

  up to 18 months

Study Arms (2)

DESFLURANE

EXPERIMENTAL

desflurane group- this group of patients will be induced with sevoflurane and maintained with desflurane during spontaneous general anaesthesia

Drug: DESFLURANE AND SEVOFLURANE

SEVOFLURANE

ACTIVE COMPARATOR

the controlled group.patients will be induced and maintained with sevoflurane through out spontaneous general anaesthesia.

Drug: DESFLURANE AND SEVOFLURANE

Interventions

DESFLURANE AND SEVOFLURANE DRUG

COMPARING THE EFFICACY IN MAINTAINANCE OF SPONTANEOUS GENERAL ANAESTHESIA USING AMBU AURA GAIN IN PEDIATRIC PATIENTS

Also known as: Suprane and Sevoflurane

DESFLURANE; SEVOFLURANE

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged: 3 years to 12 years old.
• ASA (American Society of Anesthesiologist) I
• BMI (body mass index) less than 95 centile according to age, sex, height
• Preoperative assessment shows low risk of aspiration and no features of difficult intubation.
• No history of difficult intubation or history of admission to ICU for airway complication.
• Operation duration less or equal 2 hours using AmbuAuraGain.

You may not qualify if:

• Parent refusal for study participation to give informed consent.
• Patients who had an upper respiratory tract infection (URTI) within previous 2 weeks or any respiratory disease ( bronchial asthma, hyperactive airway,sleep apnea, chronic lung disease)
• Known susceptibility to malignant hyperthermia (MH)
• History of moderate to severe hepatic dysfunction following anaesthesia with desflurane not otherwise explained.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (10)

• Lerman J, Hammer GB, Verghese S, Ehlers M, Khalil SN, Betts E, Trillo R, Deutsch J; MAPS Investigators Group. Airway responses to desflurane during maintenance of anesthesia and recovery in children with laryngeal mask airways. Paediatr Anaesth. 2010 Jun;20(6):495-505. doi: 10.1111/j.1460-9592.2010.03305.x. Epub 2010 Apr 23.

  PMID: 20456065 BACKGROUND

• Akhtam A. Shoukry, Ayman Abd Laltif,Amr Abd Fattah, Ibrahim Abd Ghani, Mohamed Serag. Isoflurane versus desflurane : hemodynamic parametres and recovery charecteristics:a comparative study.Ain Shams Journal of Anaesthesiology 2016,9:45-51

  BACKGROUND

• Demirbilek S, Togal T, Cicek M, Aslan U, Sizanli E, Ersoy MO. Effects of fentanyl on the incidence of emergence agitation in children receiving desflurane or sevoflurane anaesthesia. Eur J Anaesthesiol. 2004 Jul;21(7):538-42. doi: 10.1017/s0265021504007069.

  PMID: 15318465 BACKGROUND

• White PF, Tang J, Wender RH, Yumul R, Stokes OJ, Sloninsky A, Naruse R, Kariger R, Norel E, Mandel S, Webb T, Zaentz A. Desflurane versus sevoflurane for maintenance of outpatient anesthesia: the effect on early versus late recovery and perioperative coughing. Anesth Analg. 2009 Aug;109(2):387-93. doi: 10.1213/ane.0b013e3181adc21a.

  PMID: 19608808 BACKGROUND

• Kim EH, Song IK, Lee JH, Kim HS, Kim HC, Yoon SH, Jang YE, Kim JT. Desflurane versus sevoflurane in pediatric anesthesia with a laryngeal mask airway: A randomized controlled trial. Medicine (Baltimore). 2017 Sep;96(35):e7977. doi: 10.1097/MD.0000000000007977.

  PMID: 28858134 BACKGROUND

• Sethi S, Ghai B, Ram J, Wig J. Postoperative emergence delirium in pediatric patients undergoing cataract surgery--a comparison of desflurane and sevoflurane. Paediatr Anaesth. 2013 Dec;23(12):1131-7. doi: 10.1111/pan.12260. Epub 2013 Sep 19.

  PMID: 24102666 BACKGROUND

• Davis PJ, Cohen IT, McGowan FX Jr, Latta K. Recovery characteristics of desflurane versus halothane for maintenance of anesthesia in pediatric ambulatory patients. Anesthesiology. 1994 Feb;80(2):298-302. doi: 10.1097/00000542-199402000-00009.

  PMID: 8311312 BACKGROUND

• Jindal R, Kumra VP, Narani KK, Sood J. Comparison of maintenance and emergence characteristics after desflurane or sevoflurane in outpatient anaesthesia. Indian J Anaesth. 2011 Jan;55(1):36-42. doi: 10.4103/0019-5049.76604.

  PMID: 21431051 BACKGROUND

• Satyanarayana A, Aparanji K, Gopalakrishna K. Comparison of airway responses, haemodynamics and recovery using sevoflurane and desflurane via laryngeal mask airway in day care paediatric surgeries. J. Evid. Based Med. Healthc. 2017; 4(92), 5559-5563.

  BACKGROUND

• Kotwani MB, Malde AD. Comparison of maintenance, emergence and recovery characteristics of sevoflurane and desflurane in pediatric ambulatory surgery. J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):503-508. doi: 10.4103/joacp.JOACP_194_16.

  PMID: 29416244 BACKGROUND

MeSH Terms

Interventions

Desflurane; Sevoflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Rhendra Hardy Mohamed Zaini

  University Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Anesthetist and lecturer

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: February 25, 2021
• Study Start: January 1, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)