Spinal for Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

— Sp-Lap  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02768376
• Other study ID #: Refa32016
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2016
• Last updated: July 16, 2016
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

• coagulopathy

• Patient refusal

• previous spine surgery

• Obesity BMI more than 30

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• 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.
• 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..

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	Dkahleya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction (over a scale from 1 to 4)		24 hours	Yes
Primary	Postoperative analgesic consumption (mg morphine)		24 hours	Yes