Full Term Pregnant PatientsNCT01205204
Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia
A study testing Fentanyl and Clonidine in people with Full Term Pregnant Patients and Undergoing Lower Segment Caesarian Section, run by Pravara Institute of Medical Sciences University.
Trial summary
The purpose of this study is to evaluate the safety, quality and duration of block with the addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Full Term Pregnant Patients, Undergoing Lower Segment Caesarian Section
- What is being tested?
- Fentanyl and Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Nov 2011
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergoing Lower Segment Caesarian Section
- ASA grade I or II
- Not having any complicated pregnancy
- Not having any systemic disorders.
- Age group 20 - 35 years
Who cannot join
- Not willing for spinal anaesthesia
- Unwilling to get enrolled in this study.
- Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio placenta.
- Systemic disorders like diabetes, heart disease, chronic hypertension, pulmonary disease
- With acute fetal distress.
- With bleeding or coagulation disorders.
- Maternal haemorrhage leading to hypovolemia.
- Height less than 145 cms
About this study
Official title: A Randomized Clinical Study to Compare Different Doses of Clonidine to Fentanyl as an Adjuvant to Hyperbaric Bupivacaine 0.5% for Spinal Anesthesia in Patients Undergoing LSCS
The purpose of this study is to evaluate the safety, quality and duration of block with the addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.
Read the detailed description
All the patients selected for study will have a detailed general examination including airway assessment, spine, and systemic examination .Patient will be kept nil-by-mouth for 6 to 8 hours. Sedatives and hypnotics will be avoided in premedication as well as intraoperatively.All patients will be premedicated with antiemetic agent - Inj ondansetron(4 mg). In O.T. patient will be preloaded with R.L. 10-15 mL/kg.Pre-operative parameters like pulse rate, respiratory rate, oxygen saturation and blood pressure will be noted.
Procedure
Spinal anaesthesia will be given with 25G Quinke's needle in sitting position. Under all aseptic precautions and depending upon the groups, respective agents will be injected intrathecally.That is Group BC15 will be given 2ml of hyperbaric bupivacaine 0.5%with 15 mcg clonidine intrathecally; Group BC30 will be given 2ml of hyperbaric bupivacaine 0.5% with 30 mcg clonidine intrathecally;Group BC60 will be given 2ml of hyperbaric bupivacaine 0.5% with 60 mcg clonidine intrathecally Group BF25 will be given 2ml of hyperbaric bupivacaine 0.5% with 25mcg of fentanyl intrathecally.Each group will have a total volume of 2.5 ml made by addition of Normal saline Both the patient and anesthesiologist will be blinded to the study solutions. Syringes will be prepared immediately before the spinal injection ensuring the volumes at 2.5ml by third person knowing the code to blind the Anaesthesiologist administering the drug and later on making the observations. Pulse and blood pressure will be measured every 5 minutes for first 30minutes and thereafter every 10 minutes.Sensory block will be tested by pinprick method. Degree of motor blockade will be assessed by modified Bromage scale. In the intraoperative period, patient will be closely monitored for pulse rate, respiratory rate, SpO2, blood pressure and blood loss.
- Any side effects such as nausea, vomiting, pain, shivering, pruritis, sedation hypotension, bradycardia,urinary retention and respiratory discomfort will be noted and treated with appropriate drugs. Inj oxytocin 10U will be added to R.L. after delivery of anterior shoulder. Residual sensory blockade will be monitored and its wearing off time will be noted(when sensation to pin-prick regresses by 2 dermatomal segments).
- Residual motor blockade will be monitored and its wearing off time will be noted(when patient starts to lift legs against gravity) Post operative analgesic drugs will be given when patient's VAS score reaches > 7. (this will be taken as the time of wearing off analgesia) and the time of injection of first analgesic drug.(Inj Voveran 75mg i.m.)will be noted.VAS involves us of a 10cm line on a piece of white paper and it represents patients opinion of degree of pain.It will be explained to all patients preoperatively that one end of the line i.e '0' marks "no pain" at all, while other end i.e '10' represents "worst pain" she ever felt. Patient will rate the degree of pain by making a mark on the scale. Thus the pain score will be obtained by measuring the distance from the '0' end to the indicated mark.
Pain score 0-3 mild 3-7 moderate >7 severe The various data obtained, including different parameters measured at different time intervals, will be calculated and compared with baseline values within each group as well as with corresponding times among the groups, using appropriate test of significance. p value less than 0.05 will be taken as significant. The data will be presented by constructing various tables and graphs.
- Being tested
- Fentanyl, Clonidine
- Keywords
- Clonidine, Fentanyl, Bupivacaine, Spinal Anesthesia, Lower Segment Caesarian Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
GROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally.
ClonidineDrug
In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally.
ClonidineDrug
In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally.
clonidineDrug
In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally.
| Study group | Role | What they receive |
|---|---|---|
| BF25 (Control) | Active comparator | GROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally. Receives: Drug: Fentanyl |
| BC15(Study 1) | Experimental | GROUP BC15 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally. Receives: Drug: Clonidine |
| BC30(Study 2) | Experimental | GROUP BC30 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally. Receives: Drug: Clonidine |
| BC60 (Study 3) | Experimental | GROUP BC60 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally. Receives: Drug: clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of block
Measured by regression of sensory block by 2 dermatomal segments and residual motor blockade monitored by wearing off time (when patient starts to lift legs against gravity)
Measured: 6 hours
Secondary outcomes (6)
Demographic characteristics
Age,Height,Weight,Duration of Pregnancy etc.
Measured: 15 Minutes
Maternal safety
Measured by parameters like pulse rate, respiratory rate, SpO2, blood pressure and blood loss.
Measured: 24 Hours
Maternal side effects
Side effects such as nausea, vomiting, pain, shivering, pruritis, sedation,urinary retention and respiratory discomfort will be observed.
Measured: 24 hours
Foetal safety
Indicated by APGAR Scores
Measured: 20 Minutes
Quality of block
Sensory by pinprick method, and Motor by modified Bromage scale
Measured: 15 Minutes
Duration of postoperative analgesia
Measured by Visual Analogue Scores and time at which first rescue analgesia dose is required.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: This study was registered with Clinical Trials.gov by mistake.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Term Pregnant PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pravara Institute of Medical Sciences University
- Sponsor type
- University, hospital or other
- Investigators
- Dr.Mrs. Bhavini B Shah, MBBS DA, Principal investigator, Pravara Institute of Medical SciencesDr.Mrs.Smita S Joshi, MD DA, Principal investigator, Pravara Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205204
- Sponsor's protocol ID
- abcd123
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study to Compare Different Doses of Clonidine to Fentanyl as an Adjuvant to Hyperbaric Bupivacaine 0.5% for Spinal Anesthesia in Patients Undergoing LSCS
- ClinicalTrials.gov ID
- NCT01205204
- Acronym / sponsor ID
- abcd123
- Keywords
- Clonidine, Fentanyl, Bupivacaine, Spinal Anesthesia, Lower Segment Caesarian Section
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was registered with Clinical Trials.gov by mistake.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pravara Institute of Medical Sciences UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 20 Sep 2010 (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 purpose of this study is to evaluate the safety, quality and duration of block with the addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.
Detailed description
All the patients selected for study will have a detailed general examination including airway assessment, spine, and systemic examination .Patient will be kept nil-by-mouth for 6 to 8 hours. Sedatives and hypnotics will be avoided in premedication as well as intraoperatively.All patients will be premedicated with antiemetic agent - Inj ondansetron(4 mg). In O.T. patient will be preloaded with R.L. 10-15 mL/kg.Pre-operative parameters like pulse rate, respiratory rate, oxygen saturation and blood pressure will be noted.
Procedure
Spinal anaesthesia will be given with 25G Quinke's needle in sitting position. Under all aseptic precautions and depending upon the groups, respective agents will be injected intrathecally.That is Group BC15 will be given 2ml of hyperbaric bupivacaine 0.5%with 15 mcg clonidine intrathecally; Group BC30 will be given 2ml of hyperbaric bupivacaine 0.5% with 30 mcg clonidine intrathecally;Group BC60 will be given 2ml of hyperbaric bupivacaine 0.5% with 60 mcg clonidine intrathecally Group BF25 will be given 2ml of hyperbaric bupivacaine 0.5% with 25mcg of fentanyl intrathecally.Each group will have a total volume of 2.5 ml made by addition of Normal saline Both the patient and anesthesiologist will be blinded to the study solutions. Syringes will be prepared immediately before the spinal injection ensuring the volumes at 2.5ml by third person knowing the code to blind the Anaesthesiologist administering the drug and later on making the observations. Pulse and blood pressure will be measured every 5 minutes for first 30minutes and thereafter every 10 minutes.Sensory block will be tested by pinprick method. Degree of motor blockade will be assessed by modified Bromage scale. In the intraoperative period, patient will be closely monitored for pulse rate, respiratory rate, SpO2, blood pressure and blood loss.
- Any side effects such as nausea, vomiting, pain, shivering, pruritis, sedation hypotension, bradycardia,urinary retention and respiratory discomfort will be noted and treated with appropriate drugs. Inj oxytocin 10U will be added to R.L. after delivery of anterior shoulder. Residual sensory blockade will be monitored and its wearing off time will be noted(when sensation to pin-prick regresses by 2 dermatomal segments).
- Residual motor blockade will be monitored and its wearing off time will be noted(when patient starts to lift legs against gravity) Post operative analgesic drugs will be given when patient's VAS score reaches > 7. (this will be taken as the time of wearing off analgesia) and the time of injection of first analgesic drug.(Inj Voveran 75mg i.m.)will be noted.VAS involves us of a 10cm line on a piece of white paper and it represents patients opinion of degree of pain.It will be explained to all patients preoperatively that one end of the line i.e '0' marks "no pain" at all, while other end i.e '10' represents "worst pain" she ever felt. Patient will rate the degree of pain by making a mark on the scale. Thus the pain score will be obtained by measuring the distance from the '0' end to the indicated mark.
Pain score 0-3 mild 3-7 moderate >7 severe The various data obtained, including different parameters measured at different time intervals, will be calculated and compared with baseline values within each group as well as with corresponding times among the groups, using appropriate test of significance. p value less than 0.05 will be taken as significant. The data will be presented by constructing various tables and graphs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BF25 (Control) | Active comparator | Drug: FentanylGROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally. |
| BC15(Study 1) | Experimental | Drug: ClonidineGROUP BC15 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally. |
| BC30(Study 2) | Experimental | Drug: ClonidineGROUP BC30 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally. |
| BC60 (Study 3) | Experimental | Drug: clonidineGROUP BC60 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Undergoing Lower Segment Caesarian Section
- ASA grade I or II
- Not having any complicated pregnancy
- Not having any systemic disorders.
- Age group 20 - 35 years
Key exclusion criteria (8 listed)
- Not willing for spinal anaesthesia
- Unwilling to get enrolled in this study.
- Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio placenta.
- Systemic disorders like diabetes, heart disease, chronic hypertension, pulmonary disease
- With acute fetal distress.
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 |
|---|---|---|
| FentanylGROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally. | Drug | BF25 (Control) |
| ClonidineIn this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally. | Drug | BC15(Study 1) |
| ClonidineIn this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally. | Drug | BC30(Study 2) |
| clonidineIn this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally. | Drug | BC60 (Study 3) |
Primary outcome
Duration of block
Time frame: 6 hours
Measured by regression of sensory block by 2 dermatomal segments and residual motor blockade monitored by wearing off time (when patient starts to lift legs against gravity)
6 secondary outcomes
Demographic characteristics
Time frame: 15 Minutes
Maternal safety
Time frame: 24 Hours
Maternal side effects
Time frame: 24 hours
Foetal safety
Time frame: 20 Minutes
Quality of block
Time frame: 15 Minutes
Duration of postoperative analgesia
Time frame: 24 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
Related trials for Full Term Pregnant Patients
Not yet recruiting
Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
Maternal Health Services, Infant, Newborn
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.
Dr.Mrs. Bhavini B Shah, MBBS DA principal investigator
Pravara Institute of Medical Sciences
Dr.Mrs.Smita S Joshi, MD DA principal investigator
Pravara Institute of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Clonidine in people with Full Term Pregnant Patients and Undergoing Lower Segment Caesarian Section, run by Pravara Institute of Medical Sciences University.
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 8 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: withdrawn, as of the sponsor's last update on 21 Sep 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Duration of block (time frame: 6 hours). 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 Sep 2017.