Hemodynamic StabilityPhase 2/3NCT06735443
Comparative Efficacy & Safety of Dexmedetomidine vs Tramadol in Paeds Hernioraphy. A Caudal Anaesthesia Approach
A Phase 2/3 study testing Bupivacaine with Dexmetedomidine and Bupivacaine with Tramadol in people with Hemodynamic Stability and Post Operative Pain, run by Sahiwal medical college sahiwal at 1 site in Pakistan.
Trial summary
Among the postoperative adverse effects, pain has significant importance. Caudal block is a common technique for pediatric analgesia for infraumbilical surgeries. Because of the shortduration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Stability, Post Operative Pain, Inguinal Hernia Repair
- What is being tested?
- Bupivacaine with Dexmetedomidine and Bupivacaine with Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Mar 2021to 10 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of age 5-15 years.
- Either gender,
- Elective inguinal hernia surgery.
- ASA I-II
- Proposed duration of surgery <60 minutes.
Who cannot join
- • Emergency surgery
- Children with evidence of infection at back, allergy to trial drugs, bleeding/coagulation disorder (PT>15sec), history of developmental delay, sepsis, pre-existing neurological or spinal diseases (on medical record)
- Expected duration of surgery >120 minutes
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sahiwal Medical College Sahiwal
Sahiwal, Punjab Province, 57000
About this study
Official title: Comparison Of Dexmedetomidine Versus Tramadol As An Adjuvant With Bupivacaine In Caudal Block For Intra-Operative Hemodynamic Stability And Post-Operative Pain In Children Undergoing Inguinal Hernia Surgery
Among the postoperative adverse effects, pain has significant importance. Caudal block is a common technique for pediatric analgesia for infraumbilical surgeries. Because of the shortduration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. Tramadol has a centrally acting analgesic effect via opioid receptors.Adding Dexmedetomidine to bupivacaine has proven effectiveness for postoperative painrelief. But not much research has been conducted before regarding this comparison which can help us to find the more effective drug for induction of anesthesia.So we want to conduct this randomized trial. Sample size of 60 cases; 30 cases in each group will be included through Nonprobability convenience sampling and will be randomly divided in two groups. In group A,patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine0.5 μg/kg. In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 mins of induction and at the time of extubation. After surgery, total duration from surgery and first rescue analgesia will be noted. All the information will be recorded on proforma. Data will be entered \& analyzed by using SPSS version 20. Both groups will be compared for mean heart rate, MAP and time to first rescue analgesia by using independent samples t-test. P-value ≤0.05 will be considered as significant. So this study will be done in a local setting to get local evidence and implement the use of more appropriate drug with less postop complications, especially in pediatric age group patients. This will help to improve our practice and local guidelines.
Read the detailed description
After taking approval from hospital ethical committee, 60 children fulfilling the selection criteria will be included in the study from ward of Department of Pediatrics, DHQ Teaching Hospital, Sahiwal. An informed consent will be taken. Demographic information (name, age,gender, weight, ASA and duration of surgery) will be noted.Then children will be randomly divided in two groups by using lottery method for caudal block. In both groups children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body with dexmedetomidine 0.5μg/kg. In group B, patients will be given0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having 4 years residency experience. Heart rate and mean arterial pressure will be assessed after 5,10,15 and 30 mins of induction and at the time of extubation.Neostigmine 0.05mg/kg plus Glycopyrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. Children will be assessed for postoperative pain score. If pain score will be greater than or equal to 5 on FLACC scale, then rescue analgesia will be given and total duration from surgery and first rescue analgesia will be noted (as per operational definition). All the information will be recorded on proforma attached.
definition). All the information will be recorded on proforma (attached). pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes weight and appropriate sized endotracheal tube (ETT) according to the age. In group A, patients will be given 0.25% bupivacaine 1 mL/kg
- Being tested
- Bupivacaine with Dexmetedomidine, Bupivacaine with Tramadol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine with DexmetedomidineDrug
Also called Bupicain with Dex
children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score.
Bupivacaine with TramadolDrug
Also called Bupicain with Tramal
children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with Dexmetedomidine group | Experimental | In group A, patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg Receives: Drug: Bupivacaine with Dexmetedomidine |
| Bupivacaine with Tramadol group | Experimental | In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol Receives: Drug: Bupivacaine with Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Stability
heart rate
Measured: Heart rate will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.
Post Op Analgesia
post operative first rescue analgesia
Measured: After 24hours, children will be assessed for postoperative pain score
Hemodynamic Stability
Blood pressure
Measured: Blood pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start6 Mar 2021
- Primary completion11 Apr 2022
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahiwal medical college sahiwal
- Sponsor type
- Other government
- Collaborators
- Department of medical education
- Responsible party
- Principal investigator, Hafiz Dr Naeem Abbas, Sahiwal medical college sahiwal
- Investigators
- Adeel Riaz, MD, Study director, Sahiwal Teaching Hospital, Sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735443
- Sponsor's protocol ID
- 2094/SLMC/SWL
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Dexmedetomidine Versus Tramadol As An Adjuvant With Bupivacaine In Caudal Block For Intra-Operative Hemodynamic Stability And Post-Operative Pain In Children Undergoing Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT06735443
- Acronym / sponsor ID
- 2094/SLMC/SWL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sahiwal medical college sahiwalOther government
- Collaborators
- Department of medical education
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among the postoperative adverse effects, pain has significant importance. Caudal block is a common technique for pediatric analgesia for infraumbilical surgeries. Because of the shortduration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. Tramadol has a centrally acting analgesic effect via opioid receptors.Adding Dexmedetomidine to bupivacaine has proven effectiveness for postoperative painrelief. But not much research has been conducted before regarding this comparison which can help us to find the more effective drug for induction of anesthesia.So we want to conduct this randomized trial. Sample size of 60 cases; 30 cases in each group will be included through Nonprobability convenience sampling and will be randomly divided in two groups. In group A,patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine0.5 μg/kg. In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 mins of induction and at the time of extubation. After surgery, total duration from surgery and first rescue analgesia will be noted. All the information will be recorded on proforma. Data will be entered \& analyzed by using SPSS version 20. Both groups will be compared for mean heart rate, MAP and time to first rescue analgesia by using independent samples t-test. P-value ≤0.05 will be considered as significant. So this study will be done in a local setting to get local evidence and implement the use of more appropriate drug with less postop complications, especially in pediatric age group patients. This will help to improve our practice and local guidelines.
Detailed description
After taking approval from hospital ethical committee, 60 children fulfilling the selection criteria will be included in the study from ward of Department of Pediatrics, DHQ Teaching Hospital, Sahiwal. An informed consent will be taken. Demographic information (name, age,gender, weight, ASA and duration of surgery) will be noted.Then children will be randomly divided in two groups by using lottery method for caudal block. In both groups children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body with dexmedetomidine 0.5μg/kg. In group B, patients will be given0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having 4 years residency experience. Heart rate and mean arterial pressure will be assessed after 5,10,15 and 30 mins of induction and at the time of extubation.Neostigmine 0.05mg/kg plus Glycopyrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. Children will be assessed for postoperative pain score. If pain score will be greater than or equal to 5 on FLACC scale, then rescue analgesia will be given and total duration from surgery and first rescue analgesia will be noted (as per operational definition). All the information will be recorded on proforma attached.
definition). All the information will be recorded on proforma (attached). pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes weight and appropriate sized endotracheal tube (ETT) according to the age. In group A, patients will be given 0.25% bupivacaine 1 mL/kg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with Dexmetedomidine group | Experimental | Drug: Bupivacaine with DexmetedomidineIn group A, patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg |
| Bupivacaine with Tramadol group | Experimental | Drug: Bupivacaine with TramadolIn group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children of age 5-15 years.
- Either gender,
- Elective inguinal hernia surgery.
- ASA I-II
- Proposed duration of surgery <60 minutes.
Key exclusion criteria (3 listed)
- • Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine with DexmetedomidineAlso: Bupicain with Dexchildren will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score. | Drug | Bupivacaine with Dexmetedomidine group |
| Bupivacaine with TramadolAlso: Bupicain with Tramalchildren will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body weight and appropriately sized endotracheal tube (ETT) according to the age. Patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol. Neostigmine 0.05mg/kg plus Glycopyrrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. After 24hours, children will be assessed for postoperative pain score. | Drug | Bupivacaine with Tramadol group |
Primary outcome
Hemodynamic Stability
Time frame: Heart rate will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.
heart rate
Post Op Analgesia
Time frame: After 24hours, children will be assessed for postoperative pain score
post operative first rescue analgesia
Hemodynamic Stability
Time frame: Blood pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.
Blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeel Riaz, MD study director
Sahiwal Teaching Hospital, Sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine with Dexmetedomidine and Bupivacaine with Tramadol in people with Hemodynamic Stability and Post Operative Pain, run by Sahiwal medical college sahiwal at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Stability (time frame: Heart rate will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.