AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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
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 groups in NCT01205204
Study groupRoleWhat they receive
BF25 (Control)Active comparatorGROUP 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)ExperimentalGROUP 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)ExperimentalGROUP 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)ExperimentalGROUP 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.

  1. 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)
  1. Demographic characteristics

    Age,Height,Weight,Duration of Pregnancy etc.

    Measured: 15 Minutes

  2. Maternal safety

    Measured by parameters like pulse rate, respiratory rate, SpO2, blood pressure and blood loss.

    Measured: 24 Hours

  3. Maternal side effects

    Side effects such as nausea, vomiting, pain, shivering, pruritis, sedation,urinary retention and respiratory discomfort will be observed.

    Measured: 24 hours

  4. Foetal safety

    Indicated by APGAR Scores

    Measured: 20 Minutes

  5. Quality of block

    Sensory by pinprick method, and Motor by modified Bromage scale

    Measured: 15 Minutes

  6. 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.

  1. First posted20 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJul 2011 (estimated)
  4. Study completionNov 2011 (estimated)

Why it stopped: This study was registered with Clinical Trials.gov by mistake.

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in