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Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy

L

Lütfiye Nuri Burat Government Hospital

Status

Completed

Conditions

Gall Stone Disease
Polyp

Treatments

Procedure: combined anesthesia
Procedure: general anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02317510
HASEKI-156

Details and patient eligibility

About

The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.

Full description

Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.

Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.

Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gall stone disease, polyp

Exclusion criteria

  • Gall bladder cancer

Trial design

50 participants in 2 patient groups

group 1
Active Comparator group
Description:
Laparoscopic cholecystectomy in General Anesthesia
Treatment:
Procedure: combined anesthesia
group 2
Active Comparator group
Description:
Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
Treatment:
Procedure: general anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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