Dexmedetomidine Versus Magnesium Sulphate for Caesarean Delivery

February 25, 2017 updated by: Ahmed talaat ahmed aly, Assiut University

Effect of Adding Dexmedetomidine Versus Magnesium Sulphate to Intrathecal Bupivacaine on Spinal Block and Neonatal Outcome in Uncomplicated Caesarean Delivery

Regional anesthesia has become more popular in cesarean deliveries because most of the parturients prefer being awake during the birth process. In addition, regional anesthesia may be a safer method than general. In spinal anesthesia local anesthetics alone may not be enough for an effective postoperative analgesia and hemodynamic stability of the patient wich is crucial during cesarean section. So far many adjuvants have been used to augment the analgesia produced by intrathecal local anesthetics and to reduce their adverse effects .

Various intrathecal adjuvants to local anaesthetics have found to improve the quality and extend duration of spinal block. Prolongation of duration of spinal block is desirable both for long procedures and for postoperative pain relief. Efficacy and safty of intrathecal magnesium as analgesic adjuvant has been tested by several clinical trails in recent years.Antinociceptive effect of magnesium appears to be relevant for the management of chronic and post operative pain. These effects are primarily based on regulation of calcium influx in to the cell. Magnesium blocks calcium influx and non competitively antagonizes NMDA channels. NMDA receptor signelling plays an impartent in determining the duration of acute pain3).) addition of magnesium to spinal anaesthesia improved postoperative analgesia in orthopedic setting. addition of intrathecal magnesium sulfate to 10 mg bupivacaine plus 25µg fentanyl prolonged spinal anaesthesia in patients undergoing lower extremity surgery.

Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia.Dexmedetomidine have several beneficial actions during perioperative period. They decrease sympathetic tone with attenuation of the neuroendocrine and haemodynamic response to anaesthesia and surgery, reduce anaesthetic and opiod requirement, cause sedation and analgesia. Dexmedetomidine was first introduced into clinical practice as a short term intravenous sedative in intensive care. Like any other adjuvant dexmedetomidine is not free from adverse effects. Use of dexmedetomidine is often associated with a decrease in heart rate and blood pressure.Dexmedetomidine was used to enhance the analgesic property of local anaesthetics like lidocaine bupivacaine and ropivacaine. In vivo and in vitro studies indicated that these local anaesthetics had significant neurotoxicity. Dexmedetomidine showed protective or growth promoting properties in tissues, including nerve cells from cortex. Intrathecal dexmedetomidine has a neuroprotective effect similar to methylprednisolone.

The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2 adrenergic agonist. The local anesthetics act by blocking sodium channels, whereas the alpha 2 adrenergic agonist acts by binding to pre synapyic C fibre and post synaptic dorsal horn neurons. Intrathecal alpha 2 adrenergic agonist produce analgesia by depressing the realease of C fibre transmission by hyperpolarization of post synaptic dorsal horn neurons. Li et al observed that Glutamate is involved in excitatory neurotransmission nociception and plays an essential role in relaying noxious stimuli in the spinal cord. Intrathecal injection of alpha 2 adrenergic agonists produces potent antinociceptive effects by altering spinal neurotransmitter release and effectively treats acute pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Ahmed Talaat Ahmed

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

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age 18 to 45 years
  2. Undergo elective cesarean section under spinal anesthesia.
  3. ASA physical status Ӏ-ӀӀ .
  4. Singleton pregnancy .
  5. At least 36 weaks gestation .

Exclusion Criteria:

  1. Women with a history of cardiac , liver , or kidney diseases .
  2. Women with allergy to amide local anesthetics or medications included in the study .
  3. Women with any neurological problem .
  4. Any contraindication of regional anesthesia .
  5. Women with evidence of intrauterine growth restriction or fetal compromise .
  6. Failed or insatisfactory spinal block .

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group C
Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml
Drug: Bupivacaine
Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml
ACTIVE_COMPARATOR: Group D
Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline .
Drug: Dexmedetomidine
Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline
ACTIVE_COMPARATOR: Group M
Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with magnesium sulfate 50 mg in 0.5 ml normal saline .
Drug: Magnesium Sulfate
Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml magnesium sulfate 50 mg in 0.5 ml normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 6 hours
analgesia will be given if VAS is 4 or more
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 6 hours
effect of study drugs on the maternal heart rate
6 hours
blood pressure
Time Frame: 6 hours
effect of study drugs on the maternal mean blood pressure
6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
APGAR Score
Time Frame: 5 minutes
effect of study drugs on the APGAR fetal outcome
5 minutes
plasma concentration of stress hormones
Time Frame: 3 hours
effect of study drugs on the stress hormones levels
3 hours

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Zain E. Hassan, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

July 12, 2015

First Submitted That Met QC Criteria

February 25, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 25, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assuit university

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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