Skip to main content
OpenTrials
Completed

NCT Number: NCT02956252

Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent laparoscopic cholecystectomy (LC) under spinal versus general anesthesia.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

About this study

Laparoscopic cholecystectomy (LC) is the gold standard surgical treatment of symptomatic cholecystectomy which traditionally performed under general anesthesia. Laparoscopy has provided many advantages over open surgery for the patients; however, general anesthesia adversely affects patients' early postoperative quality of life (POQoL).

Spinal anesthesia which is a less invasive technique compared to general anesthesia has many advantages regarding the POQoL such as no need to wait for recovery from anesthesia, less nausea and vomiting, less or no pain at the end of surgery, no discomfort associated with intubation, early ambulation, fully awaken and oriented patient in the bed, and less anxious relatives.

LC has been shown to be feasible under spinal anesthesia if performed with proper technique. There are many reports demonstrated the effectiveness and safety of LC under spinal anesthesia in selected patients. However, patients with complicated gallstone disease such as acute, gangrenous or subacute cholecystitis have been considered as unfit cases for LC under spinal anesthesia because of technical difficulties. On the other hand, spinal anesthesia has also been regarded as inappropriate for patients complying with American society for anesthesiology (ASA) III and IV due to the uncontrolled anesthesia risks.

The aim of this study is to compare early postoperative outcomes of unselected consecutive patients underwent LC under spinal versus general anesthesia. If proportion of general anesthesia (PGA) / proportion of spinal anesthesia (PSA) denotes the proportion rate of outcomes in the general anesthesia group (GaG) / spinal anesthesia group (SaG), then two-sided test problem is assessed as follow:

  • Null hypothesis: H0: PGA = PSA. There is no difference between the two anesthesia techniques in terms of primary outcomes.
  • Null hypothesis: H1: PGA ≠ PSA There is a difference between the two anesthesia techniques in terms of primary outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease with no restriction for age, gender, ethnicity, disease severity, and ASA grade.

Exclusion criteria

  • Patients were excluded if they underwent concurrent surgeries, had malignancy suspicion, received or converted to open surgery, and patients who were under spinal anesthesia converted to general anesthesia.

Treatment and study plan

Spinal anesthesia

Procedure

Spinal anesthesia was used in patients who underwent LC

General Anesthesia

Procedure

General anesthesia was used in patients who underwent LC

Primary outcomes

  1. Change in pain level for the first day

    Time frame: from baseline to postoperative 1, 2, 4 and 6 hours

    Numerical rating scale (NRS) was used

  2. Change in pain level for the first month

    Time frame: From postoperative 1 week to 1 month

    Numerical rating scale was used

Secondary outcomes

  1. Complications

    Time frame: within the postoperative 1 month

    All types of complications were assessed

  2. Mortality

    Time frame: within the postoperative 1 month

    all causes of mortality were recorded

  3. Gastrointestinal quality of life index

    Time frame: change from baseline to postoperative 1 week and 1 month

    A standard form was used under the supervision of experienced independent personal

  4. Patient satisfaction

    Time frame: at postoperative 1 month

    a verbal or visual scale was used

Sponsors and collaborators

Lead sponsor

Medical Park Gaziantep Hospital

Other

Collaborators

  • Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Registry information

Official study title

Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy: a Cohort Study With Unselected Consecutive Patients

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2016
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.