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Clinical Trials/CTRI/2024/03/064243
CTRI/2024/03/064243
Not yet recruiting
Phase 1

Prevention of Emergence Delirium-A Randomised Controlled Study Comparing Intravenous Dexmedetomidine and Magnesium Sulphate In Children Undergoing Infra Umbilical Surgeries Under Sevoflurane Anaesthesia

AKHIL REJI MEKKDEN1 site in 1 country98 target enrollmentStarted: May 20, 2024Last updated:

Overview

Phase
Phase 1
Status
Not yet recruiting
Sponsor
AKHIL REJI MEKKDEN
Enrollment
98
Locations
1
Primary Endpoint
Prevention of Emergence Delirium-A Randomised Controlled Study Comparing Intravenous Dexmedetomidine and Magnesium Sulphate In Children Undergoing Infra Umbilical Surgeries Under Sevoflurane Anaesthesia

Overview

Brief Summary

BACKGROUND

Emergence delirium remains an unresolved complication of general anaesthesia in paediatric patients. Prevention of emergence delirium allows smooth recovery ,less patient and parental anxiety and prevents any major psychological impact on a long run. A large number of pharmacological and non pharmological methods have been researched over years but no single day on technique has been effective.

Dexmedetomidine, an α2  agonist has been found to be useful  in prevention of emergence delirium. The drug has sedative ,analgesic properties that helps to prevent emergence delirium. It has also found to have residual sedative effect and prolongs recovery from anaesthesia. One of the drugs that has been studied in recent years is magnesium sulphate. It has been found to have neuroprotective ,anti-inflammatory and membrane stability, analgesic property. This drug has been studied for preventing emergence delirium in adults and the results have been inconsistent .Very few studies have studied the effect of magnesium sulphate in children.

PURPOSE:

To prevent emergence delirium in paediatric patients undergoing infra umbilical surgeries under sevoflurane anesthesia.

To compare the effect of intraoperative intravenous  dexmedetomidine and         magnesium sulphate infusion in the prevention of emergence delirium in children undergoing    infraumbilical surgeries under sevoflurane anaesthesia.

To compare the effect of the dexmedetomidine and magnesium sulphate on the time of recovery.

To compare the hemodynamic stability among the two groups

We intend to study if magnesium sulphate is as effective as dexmedetomidine in prevention of emergence delirium in paediatric patients ,so that it can be used as an alternate to dexmedetomidine due to its very good recovery profile and lack of prolonged sedative effect.

Inclusion criteria:

All children between the age of 2-8 years belonging to ASA physical status I,II undergoing infra umbilical procedures under general anaesthesia are included in the study after obtaining written informed parental consent

METHODOLOGY

·       All children were kept fasting for 6 hours for solids and 2 hours for clear liquids.

·       In the preoperative holding area, all children will be subjected to a pre anaesthetic anxiety checkup using modified YALE preoperative anxiety scale.

·       The children are randomly allocated to two groups-  Group D and Group M according to computer generated numbering system.

·       In the operating room after connecting pulse oximeter ,electrocardiogram, patients are induced with 8% sevoflurane and a mixture of 50:50 Nitrous oxide and oxygen. Once adequate plane is reached an intravenous cannula is secured.

·       Patients with an intravenous cannula in place,  are induced with 1.5-2mg/kg body weight of propofol .

·       Patient also received 10mcg/kg glycopyrrolate,0.15mg/kg of ondansetron,1.5mcg/kg of fentanyl. Intubation with appropriate sized endotracheal tube will be facilitated with 0.5mg/kg of atracurium.

·       End tidal carbon dioxide and neuromuscular monitoring is done intraoperatively

·       All children will receive 0.75ml/kg of 0.25%bupivacaine in the caudal epidural space for analgesia.

·       Children in Group D will be administered a loading dose of 0.5mcg/kg of Dexmedetomidine over 10 minutes followed by an infusion of 0.2mcg/kg/hour

·       Children in Group M will receive 30mg/kg of Magnesium sulphate over 10 minutes followed by an infusion of 10mg/kg infusion.

·       Intraoperative Heart rate,Non invasive BP,SPO2 will be monitored every 5 minutes through out the surgery and anaesthesia is maintained with 0.8-1 end tidal sevoflurane and intermittent boluses of atracurium.

·       The surgical incision is made only after the completion of loading doses.

·       If there is a 20%increase in the heart rate or blood pressure after incision, which is an indication of inadequate analgesia ,we supplement 1mcg/kg of fentanyl every hour and these patients are excluded from the study.

·       The infusion of the test drugs are discontinued 10 minutes before the end of the surgery.

·       At the end of the surgery all the anaesthetic agents are discontinued neuromuscular block is reversed with 50mcg/kg neostigmine and glycopyrrolate. Child is extubated when the patient is fully awake.

·       In the post operative anaesthetic care unit the monitoring parameters include

1)SPO2 at every 5 minutes

2)Heart Rate every 5 minutes

3)PEAD score at 0,5,10,15,30,45 minutes

4)FLACC scale at 0,5,10,15,30,45 minutes

(PEAD-Paediatric Anaesthesia Emergence Delirium Scale)

(FLACC-Face, Legs, Activity, Cry, Consolability)

 Â·       If PEAD>10,Patient will be administered with 0.03mg/kg midazolam

If FLACC>5,0.5mcg/kg fentanyl is used as a rescue analgesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ALL CHILDREAN BETWEEN THE AGE OF 2-8 YEARS BELONGING TO ASA PHYSICAL STATUS 1,2 UNDERGOING INFRA UMBILICAL PROCEDURES UNDER GENERAL ANAESTHESIA ARE INCLUDED IN THE STUDY AFTER OBTAINING WRITTEN INFORMED PARENTAL CONSENT.

Exclusion Criteria

  • a)PARENTAL REFUSAL TO PARTICIPATE.
  • b)PAEDIATRIC PATIENT WITH PSYCHOLOGICAL OR BEHAVIORAL DISORDER.
  • c)PAEDIATRIC PATIENTS WITH CARDIOVASCULAR ,RENAL OR HEPATIC DISEASES.
  • d)CHILDREN WITH NEUROMUSCULAR DISEASES AND NEUROLOGICAL DISEASES.

Outcomes

Primary Outcomes

Prevention of Emergence Delirium-A Randomised Controlled Study Comparing Intravenous Dexmedetomidine and Magnesium Sulphate In Children Undergoing Infra Umbilical Surgeries Under Sevoflurane Anaesthesia

Time Frame: From end of surgery to 45mins after surgery.

Secondary Outcomes

  • To compare the hemodynamic stability between both groups.(from start of anaesthetic procedure to end of surgery)
  • to compare the effect of dexmedetomidine and magnesium sulphate on the time of recovery(from start of anaesthetic procedures to 45mins after the procedure.)

Investigators

Sponsor
AKHIL REJI MEKKDEN
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

AKHIL REJI MEKKDEN

ST JOHNS NATIONAL ACADEMY OF HEALTH SCIENCES

Study Sites (1)

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