Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dexmedetomidine + propofol, Propofol alone, Dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Sevoflurane Agitiion in Pediatric. Basic parameters: 2 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair: Randomized Double-blind Controlled Study
Overview
evaluate the synergistic efficacy of propofol and caudal dexmedetomidine for postoperative EA in pediatrics aged from to 2 to 5 years maintained on sevoflurane inhalational anesthesia and scheduled for conginital inguinal hernia repair surgeries
Detailed description
Eligibility and type of the study: This prospective randomized placebo-controlled double-blind study will be conducted after approval from the Institutional Ethics Committee and obtaining written informed consent from parents of children scheduled for conginital inguinal hernia repair procedures under general anesthesia. This study will be conducted at pediatric surgery operating theatre, Assiut University Hospitals.
Sample size:
Drugs coding and Randomization: Patients will be randomly allocated into three equal groups with the help of a computer-generated table of random numbers to receive the study drugs. One anesthesiologist, not involved in the study procedure or data collection, will prepare the study drugs in identical coded syringes. Access to these codes will be only available to one anesthesiologist who will prepare the syringes according to the study drugs used. To ensure double-blinding, the anesthetic technique and outcome data will be collected by an anesthesiologist not included in preparing study drugs or envelops coding. Also the parents will be blinded to the drug grouping of their children.
Interventions
- Drug dexmedetomidine + propofol
Comparison of caudal dexmedetomidine + propofol sevoflurane-related emergence agitation in children undergoing congenital hernia repair. - Drug Propofol alone
30 patients will receive propofol 1mg/kg before the start of skin closure, administered over 10 minutes and caudal block using 1 ml/kg of bupivacaine 0. 25 % plus 2 ml normal saline. - Drug Dexmedetomidine
patients will receive caudal dexmedetomidine block using 1 ml/kg of bupivacaine 0. 25 % mixed with dexmedetomidie 1mic/kg diluted in 2 ml normal saline
Primary outcome measures
- postoperative EA [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Age 2-7 years
- Both genders
- American society of anesthesiologists (ASA) physical state I-II
- Children undergoing sub-umbilical abdominal surgeries
Exclusion criteria
- Guardians refusal
- Congenital anomalies at the lower spine or meninges
- Increased intracranial pressure
- Skin infection at the site of injection
- Bleeding diathesis
- Known allergy to any drugs used in this study
- Children with behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
- Children on sedative or anticonvulsant medication.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Moore AD, Anghelescu DL. Emergence Delirium in Pediatric Anesthesia. Paediatr Drugs. 2017 Feb;19(1):11-20. doi: 10.1007/s40272-016-0201-5. PMID 27798810
- Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90. PMID 25535538
- Cao JL, Pei YP, Wei JQ, Zhang YY. Effects of intraoperative dexmedetomidine with intravenous anesthesia on postoperative emergence agitation/delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy: A CONSORT-prospective, randomized, controlled clinical trial. Medicine (Baltimore). 2016 Dec;95(49):e5566. doi: 10.1097/MD.0000000000005566. PMID 27930564
- Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24. PMID 26601849
- Brioni JD, Varughese S, Ahmed R, Bein B. A clinical review of inhalation anesthesia with sevoflurane: from early research to emerging topics. J Anesth. 2017 Oct;31(5):764-778. doi: 10.1007/s00540-017-2375-6. Epub 2017 Jun 5. PMID 28585095
- Cravero J, Surgenor S, Whalen K. Emergence agitation in paediatric patients after sevoflurane anaesthesia and no surgery: a comparison with halothane. Paediatr Anaesth. 2000;10(4):419-24. doi: 10.1046/j.1460-9592.2000.00560.x. PMID 10886700
- Feng Z, Shi X, Yan X, Zhu Y, Gu J, Zhu H, Yu W, Zhang S. Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial). Trials. 2021 Nov 16;22(1):811. doi: 10.1186/s13063-021-05743-2. PMID 34784941
- Ecoffey C. Safety in pediatric regional anesthesia. Paediatr Anaesth. 2012 Jan;22(1):25-30. doi: 10.1111/j.1460-9592.2011.03705.x. Epub 2011 Sep 20. PMID 21933301
Identifiers
NCT: NCT06734195 · sevoflurane gitation