| CTRI Number |
CTRI/2024/05/067865 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the quality of recovery in pediatric patients undergoing brain tumor surgeries in two different groups i.e conventionally used opioid based anaesthesia and opioid free anaesthesia |
|
Scientific Title of Study
|
Comparison of quality of recovery with opioid-based versus opioid free anaesthesia in pediatric patients undergoing brain tumor surgeries A Prospective randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Patel |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care,AIIMS,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India institute of medical sciences (AIIMS),Marudhar Industrial Area, Phase 2, Basni,Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9926554652 |
| Fax |
|
| Email |
divya2597patel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manbir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care,AIIMS,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India institute of medical sciences (AIIMS),Marudhar Industrial Area, Phase 2, Basni,Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9079864277 |
| Fax |
|
| Email |
doctor.manbir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Patel |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care,AIIMS,Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care,All India institute of medical sciences (AIIMS),Marudhar Industrial Area, Phase 2, Basni,Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9926554652 |
| Fax |
|
| Email |
divya2597patel@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Phase 2, Basni Industrial Area, Jodhpur,Rajasthan (INDIA) 342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
AIIMS Jodhpur Rajasthan 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Patel |
AIIMS JODHPUR |
Department of Anaesthesiology and Critical Care,3rd Floor,DnT Block,AIIMS,Phase 2, Basni Industrial Area, Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
9926554652
divya2597patel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid Based Anaesthesia |
Patients will receive Injection fentanyl 2mcg/kg followed by continuous fentanyl infusion (1 mcg/kg/hr) |
| Intervention |
Opioid Free Anaesthesia |
Patients will receive Injection dexmedetomidine 0.5 mcg/kg/hr over 10 minutes.Scalp block will be given with 0.5% ropivacaine according to surgical incision site (1ml of 0.5% ropivacaine will be given at each of the 6 nerves i.e. supratrochlear nerve, supraorbital nerve, auriculotemporal nerve, zygomatic temporal nerve, greater and lesser occipital nerve). Quality of recovery will be assessed at the baseline and at 24 hrs by Paediatrics QOR 15 score. |
|
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Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All the paediatric patients with age 7-18 years undergoing an elective brain tumor surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with associated congenital cardiac anomalies
2.Patients with prior hypersensitivity to the drug
3. Patients requiring postoperative mechanical ventilation
4.Patients with hypovolemic, neurogenic or septic shock |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference between quality of recovery score (Pediatric QoR 15 score) using opioid free anaesthesia and opioid based anaesthesia in the paediatric patients undergoing brain tumor. |
At Baseline and 24hrs After Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative Pain
Time of first Rescue Analgesia
PACU Stay Duration
Any Side Effects |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Group A patients will receive inj. fentanyl 2mcg/kg and Group B patients will receive inj. dexmedetomidine 0.5 mcg/kg/hr over 10 minutes. On successful bag mask ventilation, inj atracurium 0.5mg/kg will be given. The airway will be secured with appropriate size endotracheal tube. Scalp block will be given with 0.5% ropivacaine in group B according to surgical incision site (1ml of 0.5% ropivacaine will be given at each of the 6 nerves i.e. supratrochlear nerve, supraorbital nerve, auriculotemporal nerve, zygomatic temporal nerve, greater and lesser occipital nerve). Anaesthesia will be maintained with sevoflurane + O2 and air (50-50%) in both the groups. In group A, continuous fentanyl infusion (1 µg/kg/hr) and in group B, continuous dexmedetomidine infusion (0.4 mcg/kg/hr) will be started immediately after induction. In Group A, fentanyl infusion and in Group B, dexmedetomidine infusion will be stopped 15 min before the expected completion of surgery. Inj. Paracetamol (10 mg/kg) will be given in both the groups 10 min before the expected completion of surgery. After returning of spontaneous respiration and reversal of residual neuromuscular blockade using neostigmine (0.05 mg/kg) and glycopyrrolate (0.01mg/kg), patients will be extubated. The duration of anaesthesia and surgery will be noted in both the groups.. The patients will be monitored in post anaesthetic care unit (PACU) and discharged from PACU after achievement of modified Aldrete score. The time of PACU discharge will be noted and compared between the study groups.Quality of recovery will be assessed by Paediatrics QOR 15 score. QOR will be assessed at the baseline and at 24 hrs in both the groups and difference between QOR at the baseline and at 24 hrs will be compared between both the groups. The anaesthetist assessing the QOR 15 score will be different from the anaesthetist involved in the induction of anaesthesia and application of scalp block.Postoperatively, Pain score will be assessed using the numerical 0–10 visual analogue scale (VAS). The pain will be classified as mild pain (score 0–3), moderate (score 4–6) to severe (score 7–10) pain. Assessment of pain by scale will be on arrival to PACU and postoperatively at 30 min, 2 h, 6 h, 12 hand 24 h .In the PACU, the necessity for rescue analgesia will be decided by the pain score. Rescue medication will be administered when patients will have score of ≥4 on at least 2 occasions or will show obvious signs of pain. Intravenous diclofenac ( in a dose of 1.5 mg/kg ) will be used as a rescue analgesic for all the patients. The number of doses of rescue medication required and the time of administration of first dose rescue medication will also be noted. In the postoperative period, patients will also be monitored for adverse effects, including respiratory depression, vomiting. Respiratory depression will be defined as a decrease in oxygen saturation <93%, requiring oxygen by face mask. |