Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

September 17, 2019 updated by: Sana Urooj, Dow University of Health Sciences

Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75520
        • Civil Hospital Karachi
      • Karachi, Sindh, Pakistan, 75520
        • DUHS, Civil hospital Karachi (CHK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Term pregnancy Singleton ASA I and II, BMI <35, elective C/section

Exclusion Criteria:

patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group BF
hyperbaric Bupivacaine 10mg with fentanyl 10micrograms
Drug: Bupivacaine, fentanyl
Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
EXPERIMENTAL: Group BD
hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
Drug: Bupivacaine, dexmedetomidine
Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time till T10 dermatome achieved (Sec)
Time Frame: Post operative initial hour
Spinal block characteristics
Post operative initial hour
Time of maximum bromage achieved (Sec)
Time Frame: Post operative initial hour
Spinal block characteristics
Post operative initial hour
Regression time to T10 dermatome (Min)
Time Frame: Post operative initial hour
Spinal block characteristics
Post operative initial hour
Time of complete motor recovery (Min)
Time Frame: Post operative initial hour
Spinal block characteristics
Post operative initial hour
Post-operative pain score
Time Frame: 1 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
1 hour
Post-operative pain score
Time Frame: 2 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
2 hour
Post-operative pain score
Time Frame: 3 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
3 hour
Post-operative pain score
Time Frame: 4 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
4 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: 24 hours Post operative
Sensation to throw out stomach contents
24 hours Post operative
Vomiting
Time Frame: 24 hours Post operative
Act of throwing out stomach contents through mouth
24 hours Post operative
Pruritus
Time Frame: 24 hours Post operative
Unpleasing sensation on the skin that provokes to scratch
24 hours Post operative
Respiratory distress
Time Frame: 24 hours Post operative
Difficulty in breathing
24 hours Post operative
Shivering
Time Frame: 24 hours Post operative
The act of shaking slightly and uncomfortably due to felling of cold temperature
24 hours Post operative
Bradycardia
Time Frame: 24 hours Post operative
Heat rate less than <60 bpm
24 hours Post operative
Hypotension
Time Frame: 24 hours Post operative
Decrease in BP greater than 20% of baseline
24 hours Post operative

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: Baseline
Hemodynamics
Baseline
Systolic Blood Pressure
Time Frame: Immediate after giving intrathecal injection and positoning
Hemodynamics
Immediate after giving intrathecal injection and positoning
Systolic Blood Pressure
Time Frame: at 5 minute
Hemodynamics
at 5 minute
SBP
Time Frame: at 10 minute
Hemodynamics
at 10 minute
Systolic Blood Pressure
Time Frame: at 15 minute
Hemodynamics
at 15 minute
Systolic Blood Pressure
Time Frame: at 20 minute
Hemodynamics
at 20 minute
Diastolic Blood Pressure
Time Frame: Baseline
Hemodynamics
Baseline
Diastolic Blood Pressure
Time Frame: Immediate after giving intrathecal injection and positoning
Hemodynamics
Immediate after giving intrathecal injection and positoning
Diastolic Blood Pressure
Time Frame: at 5 minute
Hemodynamics
at 5 minute
Diastolic Blood Pressure
Time Frame: at 10 minute
Hemodynamics
at 10 minute
Diastolic Blood Pressure
Time Frame: at 15 minute
Hemodynamics
at 15 minute
Diastolic Blood Pressure
Time Frame: at 20 minute
Hemodynamics
at 20 minute
Heart Rate
Time Frame: Baseline
Hemodynamics
Baseline
Heart Rate
Time Frame: Immediate after giving intrathecal injection and positoning
Hemodynamics
Immediate after giving intrathecal injection and positoning
Heart Rate
Time Frame: at 5 minute
Hemodynamics
at 5 minute
Heart Rate
Time Frame: at 10 minute
Hemodynamics
at 10 minute
Heart Rate
Time Frame: at 15 minute
Hemodynamics
at 15 minute
Heart Rate
Time Frame: at 20 minute
Hemodynamics
at 20 minute
oxygen saturation
Time Frame: Baseline
Hemodynamics
Baseline
oxygen saturation
Time Frame: Immediate after giving intrathecal injection and positoning
Hemodynamics
Immediate after giving intrathecal injection and positoning
oxygen saturation
Time Frame: at 5 minute
Hemodynamics
at 5 minute
oxygen saturation
Time Frame: at 10 minute
Hemodynamics
at 10 minute
oxygen saturation
Time Frame: at 15 minute
Hemodynamics
at 15 minute
oxygen saturation
Time Frame: at 20 minute
Hemodynamics
at 20 minute
respiratory rate
Time Frame: Baseline
Hemodynamics
Baseline
respiratory rate
Time Frame: Immediate after giving intrathecal injection and positoning
Hemodynamics
Immediate after giving intrathecal injection and positoning
respiratory rate
Time Frame: at 5 minute
Hemodynamics
at 5 minute
respiratory rate
Time Frame: at 10 minute
Hemodynamics
at 10 minute
respiratory rate
Time Frame: at 15 minute
Hemodynamics
at 15 minute
respiratory rate
Time Frame: at 20 minute
Hemodynamics
at 20 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • dr.sanaurooj@yahoo.com

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings