Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

NCT ID: NCT02671227

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

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The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Detailed Description

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The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Conditions

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Gynecologic Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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intrathecal bupivacaine + Mg sulfate

intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries.

Group Type ACTIVE_COMPARATOR

intrathecal Mg sulfate.

Intervention Type DRUG

intrathecal Mg sulfate 50 mg.

intrathecal bupivacaine 15 mg.

Intervention Type DRUG

intrathecal bupivacaine 15 mg.

intrathecal bupivacaine

intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries.

Group Type ACTIVE_COMPARATOR

intrathecal bupivacaine 15 mg.

Intervention Type DRUG

intrathecal bupivacaine 15 mg.

Interventions

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intrathecal Mg sulfate.

intrathecal Mg sulfate 50 mg.

Intervention Type DRUG

intrathecal bupivacaine 15 mg.

intrathecal bupivacaine 15 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female patient.
* more than 18 years.
* undergoing elective gynecologic laparoscopic surgeries.

Exclusion Criteria

* allergy to local anesthesia.
* contraindication to spinal anesthesia.
* Significant cardiac, liver or renal dysfunction.
* Inability to informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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khaled salah mohamed

lecturer of anaesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asiut university hospital

Asiut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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intrathecal Mg in gyne. lap.

Identifier Type: -

Identifier Source: org_study_id

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