To Compare the Safety and Efficacy of Sevoflurane and Desflurane for Intraoperative Hemodynamics and Recovery in Pediatric Patients Undergoing Short Surgical Procedures Under spontaneous Respiration.

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/07/054641

Lead Sponsor: Dr Varanasi Venkata Sri Bharadwaja

Brief Summary: THIS STUDY IS TO COMPARE THE SAFETY AND EFFICACY OF SEVOFLURANE AND DESFLURANE FOR INTRAOPERATIVE HEMODYAMICS AND RECOVERY IN PEDIATRIC PATIENTS UNDERGOING SHORT SURGICAL PROCEDURES UNDER SPONTANEOUS RESPIRATION

**AIM :**

To compare Haemodynamic parameters (Heart rate and Mean art erial pressure, spo2 ) and the Recovery between Desflurane and Sevoflurane in paediatric patients undergoing short surgical procedures(Infra umbilical surgeries) under spontaneous respiration.

**OBJECTIVE :**

**PRIMARY OBJECTIVE**

To compare

1.Hemodynamics(heart rate ,mean arterial pressure,spo2)

2.Recovery Characteristics :

a)Extubation time (the time from discontinuation of anaesthetics to extubation)

b)Emergence time(the time from discontinuation of anaesthetics to achieve the Steward recovery score of 6)

**SECONDARY OBJECTIVE:**

to assess the airway adverse effects(like cough,laryngospasm,bronchospasm). emergence delirium ,post op nausea and vomiting.

**METHODOLOGY:**

Patients (n= 70) in the study will be divided in to TWO :

1.Group D Patients will receive DESFLURANE- 35 ,

2.Group S Patients will receive SEVOFLURANE- 35

A routine pre anaesthetic check up done and adequate fasting guidelines will be followed

in operation theatre, all standard monitors will be attached & Baseline pulse rate (PR), NIBP, and oxygen saturation (SpO2) will be recorded.

Premedication: IV midazolam 0.03â€‰mg/kg, and IV glycopyrrolate 0.04â€‰Âµg/kg.

Preoxygenation :for 3min with 100% o2

Induction : iv propofol 2mg/kg and airway secured with adequate size laryngeal mask airway

Maintainance of anaesthesia: 02+n2o+sevoflurane(1-3%) group s ; o2+n2o+desflurane (3-8%) group d and Mac value 1.3 will be maintained through out surgery

Analgesia will be maintained with 20ml/kg i.v paracetmol

Hemodynamic parameters (MAP,HR,SpO2) will be measured every 15mins till completion of surgery. At end all anaesthetic agents will be discontinued

Emergence time ( time from discontinuation of anaesthetics to extubation) is noted

Recovery time ( time from discontinuation of anaesthetics to achieve the steward score of 6) is noted

THE THREE PARAMETERS OF STEWARD RECOVERY SCORE:

A)consciousness

b)airway

c)movement of limbs

Incidence of post operative nausea and vomiting ,if any will be noted

After extubation , using the paediatric anaesthesia delirium(paed) score at 0, 5, 15, 30, 45, and 60 minutes, emergence delirium is monitered.

Pacu discharge time(time from receiving patient in pacu from ot till transferring them to ward after achieving modified aldrete score of>9 ) will be noted.

Duration of surgery and anaesthesia will so be noted

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patients of age 1- 10 years Patients under AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) physical status ASA I and ASA II Surgery (infra umbilical surgeries)lasting less than one hour duration Under general anaesthesia with spontaneous respiration.

Exclusion Criteria

Parents refusal Patients < 1year or >10 years Patients under AMERICAN SOCIETY OF ANAESTHESIOLOGISTS (ASA) physical status ASA III and ASA IV MALLAMPATI GRADING 3 and 4 Surgical duration exceeding 1 hour.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Recovery Characteristics :	60 minutes
To compare	60 minutes
1.Hemodynamics(heart rate ,mean arterial pressure,spo2)	60 minutes
a)Extubation time (the time from discontinuation of anaesthetics to extubation)	60 minutes
b)Emergence time(the time from discontinuation of anaesthetics to achieve the Steward recovery score of 6)	60 minutes

Secondary Outcome Measures

Name	Time	Method
To assess the airway adverse effects(like cough,laryngospasm,bronchospasm). emergence delirium ,post op nausea and vomiting.	60 minutes

Trial Locations

Locations (1): Institute of Medical Science and Sum Hospital
🇮🇳
Khordha, ORISSA, India
Institute of Medical Science and Sum Hospital
🇮🇳Khordha, ORISSA, India
Varanasi Venkata Sri Bharadwaja
Principal investigator
7013599032
bharadwajdoc93@gmail.com