| CTRI Number |
CTRI/2024/03/063544 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparing the effectiveness of Ketamine-Dexmedetomidine vs. ketamine-midazolam combination for providing sedation and analgesia in children undergoing infraumbilical surgeries under caudal anesthesia. |
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Scientific Title of Study
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Ketamine-Dexmedetomidine Vs Ketamine-Midazolam combination for peri-operative Sedo-analgesia in preschool children undergoing infraumbilical surgeries under caudal anaesthesia - A comparative randomized study |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshu Dhawan |
| Designation |
PG 3rd year anesthesia resident |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
Department of Anaesthesia, sp medical college
PBM Hospital Bikaner, Rajasthan
Bikaner RAJASTHAN 334001 India |
| Phone |
09461059340 |
| Fax |
|
| Email |
drhimanshudhawan@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Kanta Bhati |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
Department of anaesthesia sp medical college and A.G of hospitals
Bikaner RAJASTHAN Bikaner India |
| Phone |
09413466688 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Kanta Bhati |
| Designation |
Senior Professor |
| Affiliation |
Sardar Patel Medical College Bikaner |
| Address |
department of anaesthetics sp medical college and A.G. of hospitals
Bikaner RAJASTHAN Bikaner India |
| Phone |
09413466688 |
| Fax |
|
| Email |
drkantabhati67@gmail.com |
|
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Source of Monetary or Material Support
|
| Sardar Patel Medical College,
SP medical college Road, PBM Hospital , Sardar Patel colony, Bikaner, Rajasthan 334001 |
|
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Primary Sponsor
|
| Name |
Sardar Patel Medical College Bikaner Rahasthan |
| Address |
Department of Anesthesiology Sardar Patel medical college Bikaner |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshu Dhawan |
Sardar Patel Medical College |
Department of anesthesiology OT -A block PBM hospital,Sardar Patel medical college Bikaner Bikaner RAJASTHAN |
09461059340
drhimanshudhawan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel Medical College,bikaner |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K37||Unspecified appendicitis, (3) ICD-10 Condition: Q531||Undescended testicle, unilateral, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal Anaesthesia under sedo-Analgesia |
Under all aseptic precautions a sterile blunt 22-gauge needle was introduced in the caudal space by identifying sacral hiatus in between two sacral cornu. after confirming caudal epidural space by negative aspiration of blood and CSF, 0.25% bupivacaine (1 ml/kg) was injected slowly over 60s. Then, the patient was turned to supine position and level of sedation was assessed using RASS. |
| Comparator Agent |
Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination |
Intravenous bolus dose of inj.Dexmedetomidine 1mcg/kg or inj. Midazolam 0.05mg/kg was given followed by infusion of either inj. Dexmedetomidine 0.7mcg/kg/hr or Inj. Midazolam 0.1mg/kg/hr via infusion pump as per the allocated group. The Richmond Agitation Sedation Score (RASS) was used to check the level of sedation. When the RASS score was ≤ 2 the child was put in lateral position and inj. ketamine 2mg/kg was given and patient was oxygenated with facemask/nasal prongs at the rate 4-6 L/min. Under all aseptic precautions a sterile blunt 22-gauge needle was introduced in the caudal space by identifying sacral hiatus in between two sacral cornu. The needle was inserted at a 60-degree angle and the needle was advanced until a “pop†was felt. The needle was then lowered to a 20-degree angle and advanced an additional 2-3 mm to make sure the bevel was in the caudal epidural space, after confirming caudal epidural space by negative aspiration of blood and CSF, 0.25% bupivacaine (1 ml/kg) was injected slowly over 60s. Then, the patient was turned to supine position and level of sedation was assessed using RASS. Additional sedative doses of inj. Ketamine 1mg/kg was given as required intraoperatively.
Surgery will be allowed after 15 -20 mins of caudal block.Near the end of surgery the infusion pump delivering the allocated drug will be stopped and the level of sedation will be recorded using RASS before shifting to PACU when RASS more than -2.
After surgery patient will be shifted to PACU with stable hemodynamics and oxygen saturation 95% on room air. Sedation score will be assessed in PACU at 30 min and then at 1h, 2h,3h & so on using Steward Recovery Score. Surgeon and parent’s satisfaction and adverse events will be recorded. We will conclude our study when the steward recovery score will be more than or equal to 6.
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I to III
2. Infraumbilical elective surgeries
|
|
| ExclusionCriteria |
| Details |
1. Patient’s parents or caretaker’s refusal.
2. Allergy to the drugs used in the study.
3. Pre-existing neuromuscular disorder or spinal deformities.
4. Raised ICT (Intra Cranial Tension).
5. Coagulation defect.
6. Local site infection.
7. Severe hypovolemia
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To Compare the Perioperative Sedo-Analgesic Efficacy of Intravenous Ketamine-Dexmedetomidine and Ketamine-Midazolam Combination in Paediatric Patients Posted for Infraumbilical Surgeries Under Caudal Epidural Block to-
1. observe limb movement at time of needle prick for caudal block.
2. observe onset time and level of sedation.
3. observe intraoperative hemodynamic parameters.
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till end of the surgery.
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Secondary Outcome
|
| Outcome |
TimePoints |
1) To observe quality and duration of postoperative sedation.
2) Surgeon satisfaction.
3) To observe any complications and side effects.
|
till the drug effect is over. |
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
15/03/2024 |
| 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="0" Months="3" Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Unlike adults,
children are more anxious and uncooperative during invasive and painful
clinical procedures. Sedation and analgesia are required to keep the child immobile
to facilitate painful procedures.
Various Sedo-analgesic drugs such as
ketamine, dexmedetomidine, midazolam, and propofol either alone or in
combination are commonly used for several painful invasive procedures with
variable degrees of success.
Caudal
epidural analgesia is one of the most popular and commonly performed regional
blocks in pediatric anesthesia.
Caudal blocks combined with
periprocedural sedation are an efficient way to offer perioperative analgesia
for painful infraumbilical interventions.
They enable not only early ambulation
but also perioperative hemodynamic stability and spontaneous breathing in
children with cardiopulmonary co-morbidities.
Bupivacaine has been in clinical use for
more than 30 yr and is widely used for caudal epidural analgesia in children
because of its long duration of action and beneficial ratio of sensory to motor
block. The combination of Dexmedetomidine-Ketamine (DexKet) and
Midazolam-Ketamine (MiKe) seems to have favorable
characteristics in the pediatric population.
Ketamine is an anesthetic and analgesic
agent with a wide range of applications in paediatric anesthesia. Ketamine (KET) is a phencyclidine derivative whose action
is due to the central dissociation of the cortex from the limbic system
providing both sedative and analgesic properties while preserving upper airway
muscular tone and respiratory drive. It has a rapid onset with a short duration of action that induces good
analgesia, sedation, and amnesia with a rapid recovery. ketamine‑induced agitation can be overcome by
co‑administration of other drugs. Numerous studies have been tried to compare
different drugs such as midazolam, dexmedetomidine (Dex), propofol, clonidine, and
haloperidol to reduce these adverse responses.
Dexmedetomidine (DEX) is a specific
central alpha 2-adrenergic agonist that is associated with sedative and
analgesic sparing effects, reduced delirium and agitation, perioperative
sympatholytic, cardiovascular stabilizing effect and preservation of respiratory
function.
When
used together, DEX may prevent tachycardia, hypertension, salivation and
emergence phenomena from KET, whereas KET may prevent bradycardia and
hypotension which has been reported with DEX. An additional benefit of rapid
onset of sedation.
Midazolam is a benzodiazepine used for procedural
sedation, and to treat severe agitation. Midazolam induces
sleepiness, decreases anxiety, and causes amnesia.It has a fast onset time for sedative effects and a fast recovery
period.
The combination of midazolam and ketamine provides
effective procedural sedation and analgesia and appears to be safe in pediatric
patients.
Therefore, we
planned to compare the efficacy of the Dexmedetomidine-Ketamine
and Midazolam- Ketamine combination for sedo-analgesia in pediatric
patients undergoing infraumbilical surgeries under caudal epidural block.
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