General Anaesthesia Clinical Trial
Official title:
Comparing the Efficacy Between Desflurane and Sevoflurane in Miantainance of Spontaneous General Anaesthesia Using Ambu Aura Gain in Paediatrics Patients
Verified date | September 2023 |
Source | Universiti Sains Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 80 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | University of Science Malaysia Hospital | Kubang kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the blood pressure intraoperatively between desflurane and sevoflurane. | by measuring the blood pressure | up to 18 months | |
Primary | To compare the heart rate intraoperatively between desflurane and sevoflurane. | by measuring the heart rate | up to 18 months | |
Primary | To compare the mean arterial pressure intraoperatively between desflurane and sevoflurane. | by measuring the mean arterial pressure | up to 18 months | |
Secondary | To compare the emergence time ( interval from gas being off to patient awake). | to time how many minutes | up to 18 months | |
Secondary | To compare the respiratory events intraoperative and post operative | to observe for the signs :breath holding, bronchospasm,coughing, secretions,desaturations | up to 18 months |
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