Spinal for Laparoscopic Cholecystectomy (Sp-Lap)

Mansoura University

Status: Unknown

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: General anesthesia; Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)

Study type: Interventional

Funder types: Other

Identifiers

NCT02768376

Refa32016

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients scheduled for laparoscopic cholecystectomy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

General anesthesia group

Active Comparator group

Description:

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..

Treatment:

Drug: General anesthesia

Spinal anesthesia group

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)