Spinal for Laparoscopic Cholecystectomy (Sp-Lap)

M

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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