hypospadias hypospadias dexmedetomidine pudendal nerve block postoperative pain
Conditions
Interventions
Patients will be premedicated with oral midazolam 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to surgery. Standard monitors (oxygen saturation,
electro-
cardiography,
noninvasive blood pressure) will be applied in the operating room before induction of anesthesia. Anesthesia will be induced by propofol 3-
4 mg/kg if an intravenous (IV) cannula present
or 8% sevoflurane in 100% oxygen following by venous access if the patient does not have an IV cannula. Once the IV cannula is established,
fentanyl 1.0 mcg/kg and cisatracurium 0.15 mg/kg will be given. After reaching an adequate anesthetic depth,
a proper-
size orotracheal tube (size according to the patient’s age) will be inserted. Anesthesia will be maintained with sevoflurane and 50% N2O in oxygen under control ventilation. End-
tidal sevoflurane concentration will be monitored with keeping the sevoflurane concentration about 1.0 minimal alveolar concentration (MAC) according to the child age. After ensuring that the child is
the anesthesia care team including an attending anesthesiologist and a nurse will be asked to leave the operating theater. Then the block team (a principle investigator,
an anesthesia resident and a nurse anesthetist) will come to take over the patient care. The LA solution of DEX group will be prepared by adding 0.5 % bupivacaine 5 ml to NSS 5 ml and dexmedetomidine
Hospira,
Illinois,
USA) 0.25 ml in a 10 ml syringe for children body weight ≤ 25 kg and adding 0.5 % bupivacaine 10 ml to NSS 10 ml and dexmedetomidine 0.5 ml in a 20 ml syringe for children body weight > 25 kg. The f
Experimental Drug,Active Comparator Drug
DEX group,NON-
Sponsors
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Faculty of medicine,
Maharaj Nakorn Chiangmai Hospital,
Chiang May University
Eligibility
Sex/Gender
All
Age
1 Years to 7 Years
Inclusion criteria
Inclusion criteria: 1. Children age 1 to 7 years 2. American Society of Anesthesiologists (ASA) class I - II 3. Undergo elective hypospadias repair 4. I’m appreciate to participate in this study with sign
Exclusion criteria
Exclusion criteria: 1. Refuse regional block 2. Obvious anatomical anomalies e.g. sacral or pelvic malformations 3. History of bupivacaine, dexmedetomidine, paracetamol and ibuprofen allergy 4. History of coagulopathy 5. History of renal or liver disease 6. Infection of the injection site 7. Spinal abnormality e.g. myelomeningocele or tether cord 8. Developmental disability e.g. attention deficit or cerebral palsy 9. Body Mass Index (BMI) > 30 kg/m2 10. Patients who have conduction system pathology or receiving AV nodal slowing agents 11. I can refuse or withdrawn anytime during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients require analgesics in the first 24 hour Post-operative period in PACU and surgical ward the number of patients requiring both intravenous fentanyl in the PACU and oral ibuprofen at the sur | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative fentanyl requirement Intraoperative period The total dose of intraoperative fentanyl (mcg),Total postoperative analgesics consumption 48 hours Post-operative period The total doses of postoperative both fentanyl (mcg) and ibuprofen (mg),Time to first postoperative analgesics requirement 48 hours Post-operative period The first time to request postoperative analgesia (hours after the operation),Postoperative pain intensity 48 hours Post-operative period The CHEOPS PS at 5, 30 and 60 min and every 30 min thereafter in PACU and at 2,6,12,24,36 and 48 hrs,Block success rate Intraoperative period Patient’s HR and MAP is stable within 10% of the pre-incision level after skin is incised,Hemodynamics parameters Intraoperative and 48 hours Post-operative period The intraoperative and postoperative trends of HR (beats per minute) and MAP (mmHg),Extubation time Intraoperative The time from the end of anesthesia (stop anesthetics) to removal of endotracheal tube (minutes),Total anesthetic time Intraoperative The time interval between start anesthesia to the time of the patient is transfered to PACU (minutes,Recovery time PACU arrival time until patients meet ≥ 6 of modified Steward recovery score The time of discontinuing the anesthetics until modified Steward recovery score ≥ 6 (minutes),The PACU discharge time Duration from arriving to PACU until discharged from the PACU to the ward with fulfil of criteria Duration from arriving to PACU until discharged from the PACU to the ward with fulfil of criteria (,Degree of postoperative agitation PACU period The PAED score and requirement of propofol (numbers of patients needing propofol for ED treatment,The adverse effects related to dexmedetomidine Post-operative period e.g. nausea/ vomiting, hypotension, bradycardia or sedation,Parental satisfaction score Post-operative period Satisfaction levels of the parents are given using the 3-point scal | — |
Countries
Thailand
Contacts
Public ContactWitchaya Supaopaspan
Mahidol University
Outcome results
None listed