DexmedetomidineNCT05469529
Bupivacaine Alone vs Bupivacaine and Dexmed in Cesarean Deliveries
A study testing Dexmedetomidine in people with Dexmedetomidine, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 15 Oct 2022
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant females of age 18-45 years
- ASA physical status II
- Body Mass Index (BMI) of 18-35 kg/m2
Who cannot join
- Any relative or absolute contra-indication to spinal anesthesia
- Allergy to dexmedetomidine
- Subjects with pre-existing non-obstetric medical co-morbidities
- Patient refusal for spinal technique
- Obstetrics emergencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Intrathecal Hyperbaric Bupivacaine Alone Versus Hyperbaric Bupivacaine Combined With Dexmedetomidine in Cesarean Section Deliveries
The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination.
Read the detailed description
After approval from hospital ethical committee, parturient scheduled for elective Cesarean delivery falling in ASA II status, aged 18 - 45, with a BMI of 18-35kg/m2 will be allocated to either of the two groups B and D according to systemic randomized sampling technique, with every 3rd patient being enrolled in the study. The patients falling on odd numbers will be allocated group B and those falling on even numbers will be allocated group D. Written informed consent will be taken for enrollment in study. Performa questionnaire data will be collected by researcher herself (Annexure VII).
All parturients will be premedicated with Tab Omeprazole 20mg at 6:00 hours with a sip of water. Two 18G IV cannulas will be maintained in Operation Theater (OT). All patients will be pre-hydrated with Lactated Ringer's solution at rate of 20ml/kg by OT staff. On arrival to operating room standard monitoring consisting of pulse-oximeter, non-invasive blood pressure (NIBP) and ECG will be attached and baseline readings checked and recorded.
Intrathecal drugs will be prepared by the researcher herself. Patient's back will be prepared using aseptic measures, L3-L4 space will be identified and local anesthetic infiltrated. After 2 min 25 gauge pencil point spinal needle of B-Braun will be introduced. After obtaining free flow of CSF 2ml of 0.5% hyperbaric Bupivacaine 2 ml will be injected to Group B and 2ml of 0.5% bupivacaine mixed with 5µg dexmedetomidine will be injected in Group D, patient will be immediately placed in supine position. Timer will be started by the OT assistant as soon as the drug is injected. Spinal puncture will be performed by Trainee researcher herself who had experience of more than 200 spinal blocks.
Data collection will be done by fellow colleague of equal experience. Sensory blockade will be tested using pinprick method with a blunt 27G hypodermic needle every 1 min till loss of sensation at xiphoid (T6 level). Quality of motor blockade will be assessed by modified Bromage scale (Annexure I) at 3 mins then every 1 min till Bromage I motor block is achieved. Intra-operative hypotension (decrease in mean BP of more than 20%) will be treated with 3 - 6 mg ephedrine and bradycardia (HR < 60bpm) will be treated with 0.4mg atropine. Post-operative analgesia will be assessed half hourly for the 1st 3 hours, then 1 hourly using visual analogue scale (0-10) till the time to 1st request for analgesics or VAS ≥ 4, whichever comes first. Injection tramadol 50mg and injection paracetamol 1g will be used as rescue analgesia. Injection paracetamol will be given 6 hourly after the first dose for 24 hours. Duration of motor block will also be assessed via the Bromage Score along with assessment of VAS score. Time to regaining of the full flexion of knees and hips will be recorded.
- Conditions
- Dexmedetomidine
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
5mcg dexmedetomidine to be given intrathecally along with 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | No intervention | Participants to be given 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries. |
| Bupivacaine + Dexmedetomidine | Active comparator | Participants to be given 5mcg dexmedetomidine in addition to 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Sensory Block
Mean time to loss of sensation to pin prick using a 27 G blunt needle at the level of the xiphoid (T6) from the time of injection of drug intrathecally.
Measured: 8 mins
Onset of Motor Block
Mean time taken to reach Bromage Score I from the time of injection of drug intrathecally
Measured: 8 mins
Duration of Sensory Block
Mean time from spinal injection to the 1st request for analgesics or VAS ≥ 4; whichever comes first.
Measured: 8 hours
Duration of Motor Block
Mean time from spinal injection to regaining of Bromage score 4
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start15 Apr 2022
- Primary completion15 Sep 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rida Amjad Qureshi, KRL Hospital, Islamabad
- Investigators
- Rida Qureshi, Principal investigator, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469529
- Sponsor's protocol ID
- Dexmed 1
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Intrathecal Hyperbaric Bupivacaine Alone Versus Hyperbaric Bupivacaine Combined With Dexmedetomidine in Cesarean Section Deliveries
- ClinicalTrials.gov ID
- NCT05469529
- Acronym / sponsor ID
- Dexmed 1
- Conditions
- Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 21 Jul 2022 (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.
The purpose of the study is to compare the onset and duration of sensory and motor block after spinal anesthesia between intrathecal bupivacaine alone vs intrathecal bupivacaine and dexmedetomidine combination.
Detailed description
After approval from hospital ethical committee, parturient scheduled for elective Cesarean delivery falling in ASA II status, aged 18 - 45, with a BMI of 18-35kg/m2 will be allocated to either of the two groups B and D according to systemic randomized sampling technique, with every 3rd patient being enrolled in the study. The patients falling on odd numbers will be allocated group B and those falling on even numbers will be allocated group D. Written informed consent will be taken for enrollment in study. Performa questionnaire data will be collected by researcher herself (Annexure VII).
All parturients will be premedicated with Tab Omeprazole 20mg at 6:00 hours with a sip of water. Two 18G IV cannulas will be maintained in Operation Theater (OT). All patients will be pre-hydrated with Lactated Ringer's solution at rate of 20ml/kg by OT staff. On arrival to operating room standard monitoring consisting of pulse-oximeter, non-invasive blood pressure (NIBP) and ECG will be attached and baseline readings checked and recorded.
Intrathecal drugs will be prepared by the researcher herself. Patient's back will be prepared using aseptic measures, L3-L4 space will be identified and local anesthetic infiltrated. After 2 min 25 gauge pencil point spinal needle of B-Braun will be introduced. After obtaining free flow of CSF 2ml of 0.5% hyperbaric Bupivacaine 2 ml will be injected to Group B and 2ml of 0.5% bupivacaine mixed with 5µg dexmedetomidine will be injected in Group D, patient will be immediately placed in supine position. Timer will be started by the OT assistant as soon as the drug is injected. Spinal puncture will be performed by Trainee researcher herself who had experience of more than 200 spinal blocks.
Data collection will be done by fellow colleague of equal experience. Sensory blockade will be tested using pinprick method with a blunt 27G hypodermic needle every 1 min till loss of sensation at xiphoid (T6 level). Quality of motor blockade will be assessed by modified Bromage scale (Annexure I) at 3 mins then every 1 min till Bromage I motor block is achieved. Intra-operative hypotension (decrease in mean BP of more than 20%) will be treated with 3 - 6 mg ephedrine and bradycardia (HR < 60bpm) will be treated with 0.4mg atropine. Post-operative analgesia will be assessed half hourly for the 1st 3 hours, then 1 hourly using visual analogue scale (0-10) till the time to 1st request for analgesics or VAS ≥ 4, whichever comes first. Injection tramadol 50mg and injection paracetamol 1g will be used as rescue analgesia. Injection paracetamol will be given 6 hourly after the first dose for 24 hours. Duration of motor block will also be assessed via the Bromage Score along with assessment of VAS score. Time to regaining of the full flexion of knees and hips will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | No intervention | –Participants to be given 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries. |
| Bupivacaine + Dexmedetomidine | Active comparator | Drug: DexmedetomidineParticipants to be given 5mcg dexmedetomidine in addition to 2ml of 0.5% bupivacaine intrathecally for elective cesarean section deliveries. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant females of age 18-45 years
- ASA physical status II
- Body Mass Index (BMI) of 18-35 kg/m2
Key exclusion criteria (5 listed)
- Any relative or absolute contra-indication to spinal anesthesia
- Allergy to dexmedetomidine
- Subjects with pre-existing non-obstetric medical co-morbidities
- Patient refusal for spinal technique
- Obstetrics emergencies
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex5mcg dexmedetomidine to be given intrathecally along with 0.5% bupivacaine. | Drug | Bupivacaine + Dexmedetomidine |
Primary outcome
Onset of Sensory Block
Time frame: 8 mins
Mean time to loss of sensation to pin prick using a 27 G blunt needle at the level of the xiphoid (T6) from the time of injection of drug intrathecally.
Onset of Motor Block
Time frame: 8 mins
Mean time taken to reach Bromage Score I from the time of injection of drug intrathecally
Duration of Sensory Block
Time frame: 8 hours
Mean time from spinal injection to the 1st request for analgesics or VAS ≥ 4; whichever comes first.
Duration of Motor Block
Time frame: 8 hours
Mean time from spinal injection to regaining of Bromage score 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Dexmedetomidine
Active, not recruitingPhase 4
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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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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.
Rida Qureshi principal investigator
KRL Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Dexmedetomidine, run by KRL Hospital, Islamabad 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 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rida Qureshi (+923189301930, ridaqureshi00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of Sensory Block (time frame: 8 mins). The study lists 4 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 21 Jul 2022.