Spinal for Laparoscopic Cholecystectomy

NCT02768376 | Unknown DMC

• 1 other identifier: Refa32016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction (over a scale from 1 to 4)

  24 hours

• Postoperative analgesic consumption (mg morphine)

  24 hours

Study Arms (2)

General anesthesia group

ACTIVE COMPARATOR

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..

Drug: General anesthesia

Spinal anesthesia group

EXPERIMENTAL

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.

Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)

Interventions

Bupivacaine with Fentanyl (Spinal Anesthesia) 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.

Also known as: intrathecal

Spinal anesthesia group

General anesthesia 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..

General anesthesia group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for laparoscopic cholecystectomy

You may not qualify if:

• coagulopathy
• Patient refusal
• previous spine surgery
• Obesity BMI more than 30

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Fentanyl; Anesthesia, Spinal; Injections, Spinal; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 11, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

EG (1)