Pediatric Spinal AnesthesiaNCT01661803
Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
An observational study of Pediatric Spinal Anesthesia, run by ACPM Medical College.
Trial summary
The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Spinal Anesthesia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jan 2012
- Phase
- Observational
- 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients undergoing surgeries below T8 dermatome upto two hours duration.
Who may be able to join
- ASA grade-1 physical status.
- weight 5-35kg
- age-3 to 10 yrs
Who cannot join
- patients with known sensitivity to drugs to be used.
- gross spinal deformity
- patients in whom regional anesthesia is contraindicated.
- patients with peripheral neuropathy.
- patient with hemodynamic instability.
About this study
The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.
Read the detailed description
In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.
American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.
Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.
The patients studied across the group did not vary much with respect to age, weight and sex distribution.
- Conditions
- Pediatric Spinal Anesthesia
- Keywords
- bupivacaine, clonidine, pediatric spinal, efficacy, duration, quality, side effects, intrathecal bupivacaine alone, bupivacaine plus clonidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group-A and group-B | Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine). | |
| group-A and group--B | Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startNov 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Spinal AnesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACPM Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.NAGESH JAMBURE, ACPM Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661803
- Sponsor's protocol ID
- acpm anesthesia.dhule.
- Status last verified
- Aug 2012
- First submitted
- 4 Aug 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation
- ClinicalTrials.gov ID
- NCT01661803
- Acronym / sponsor ID
- acpm anesthesia.dhule.
- Conditions
- Pediatric Spinal Anesthesia
- Keywords
- bupivacaine, clonidine, pediatric spinal, efficacy, duration, quality, side effects, intrathecal bupivacaine alone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ACPM Medical CollegeUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- 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.
The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.
Detailed description
In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome.
American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally.
Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally.
The patients studied across the group did not vary much with respect to age, weight and sex distribution.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group-A and group-B | – | –Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine). |
| group-A and group--B | – | –Group-A (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15kg) and Group-B (0.5% hyperbaric bupivacaine 0.4 mg/kg for 5-15 kg or 0.3mg/kg for >15 with 1 mcg/kg preservative free clonidine). |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- prospective,randomized,double blind study cariied in 60 ASA grade 1 pediatric patients undergoing surgeries below T8 dermatome upto two hours duration.
Key inclusion criteria (3 listed)
- ASA grade-1 physical status.
- weight 5-35kg
- age-3 to 10 yrs
Key exclusion criteria (5 listed)
- patients with known sensitivity to drugs to be used.
- gross spinal deformity
- patients in whom regional anesthesia is contraindicated.
- patients with peripheral neuropathy.
- patient with hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Aug 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Spinal Anesthesia, run by ACPM Medical College.
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 3 inclusion and 5 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 10 Aug 2012.