Spinal for Laparoscopic Cholecystectomy

NCT ID: NCT02768376

Last Updated: 2016-07-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-10-31

Brief Summary

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In this study, the investigators will study spinal anesthesia for laparoscopic cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a primary variable, intraoperative complications, postoperative analgesic requirements, postoperative nausea and vomiting, patient hospital stay (secondary variables).

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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General anesthesia group

General anesthesia group: Standard anesthetic technique will be applied.Anesthesia will be induced by propofol 1% (1-2 mg/kg), Fentanyl 1-2 mic/kg, and Atracurium 0.5 mg/kg then according to train of four response. Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type DRUG

Induction by propofl 1.5-2 mg/kg, Fentanyl 1-2 mic/kg and atracrium 0.5 mg/kg Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..

Spinal anesthesia group

While in sitting position; intrathecal injection using 25 G spinal needle using 3 mls of Bupivacaine 0.5% with 20 mic Fentanyl, at L 2-3 level the patient head will be lowered till sensory blockade of T6 obtained at least.

Group Type EXPERIMENTAL

Bupivacaine with Fentanyl (Spinal Anesthesia)

Intervention Type DRUG

Intrathecal injection of 15 mg Bupivacaine 0.5% at L 2-3 level mixed with 20 µ Fentanyl. Patients head will be lowered till sensory level of T 6 is abstained.

Interventions

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Bupivacaine with Fentanyl (Spinal Anesthesia)

Intrathecal injection of 15 mg Bupivacaine 0.5% at L 2-3 level mixed with 20 µ Fentanyl. Patients head will be lowered till sensory level of T 6 is abstained.

Intervention Type DRUG

General anesthesia

Induction by propofl 1.5-2 mg/kg, Fentanyl 1-2 mic/kg and atracrium 0.5 mg/kg Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..

Intervention Type DRUG

Other Intervention Names

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intrathecal

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for laparoscopic cholecystectomy

Exclusion Criteria

* coagulopathy
* Patient refusal
* previous spine surgery
* Obesity BMI more than 30
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university

Al Mansurah, Dkahleya, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Alreafey Kandeel, MD

Role: primary

00201008158591

Other Identifiers

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Refa32016

Identifier Type: -

Identifier Source: org_study_id

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