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The impact of general anesthesia applied alone or with epidural anesthesia on stress response caused by laparoscopic cholecystectomy, using hormonal, metabolic and inflammatory markers.

A randomized trial to evaluate the impact of general anesthesia alone or supplemented with epidural anesthesia on surgical stress response during laparoscopic cholecystectomy for uncomplicated symptomatic cholelithiasis, using stress hormones, glucose and C-reactive protein, as potential markers.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001135606
Enrollment
60
Registered
2014-10-27
Start date
2014-04-15
Completion date
2014-09-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to investigate the impact of general anesthesia alone or supplemented with epidural anesthesia on the perioperative response to surgical stress. Thus, we will study the comparable changes in hemodynamics, stress hormones (cortisol, human growth hormone and prolactin), glucose levels and C-reactive protein levels in patients undergoing laparoscopic cholecystectomy procedures. We would like to test the hypothesis that general anesthesia supplemented with epidural anesthesia exerts a favourable impact on surgical stress hormone compared to general anesthesia alone.

Interventions

Patients undergoing laparoscopic cholecystectomy will be randomly assigned, to receive either general anesthesia or lumbar epidural anesthesia supplemented by general anesthesia. In general anesthesia group, following preoxygenation and an intravenous induction sequence consisting of propofol (2.5 mg/kg), lidocaine (1-1.5 mg/kg), fentanyl (2 microg/kg) and cis-atracurium (0.2 mg/kg), laryngoscopy and orotracheal intubation will be performed. In lumbar epidural anesthesia with supplemental gener

Patients undergoing laparoscopic cholecystectomy will be randomly assigned, to receive either general anesthesia or lumbar epidural anesthesia supplemented by general anesthesia. In general anesthesia group, following preoxygenation and an intravenous induction sequence consisting of propofol (2.5 mg/kg), lidocaine (1-1.5 mg/kg), fentanyl (2 microg/kg) and cis-atracurium (0.2 mg/kg), laryngoscopy and orotracheal intubation will be performed. In lumbar epidural anesthesia with supplemental general anesthesia group, an epidural catheter will be placed through the intervertebral space between T12 and L1 or L1 and L2 before induction of anesthesia. Then, a bolus dose of ropivacaine 10% (15 +/- 2 ml) will be injected while epidural anesthesia will be considered as adequate when sensory blockade reaches the T4 level. Induction of anesthesia will be identical to the one previously described for general anesthesia group. In both groups, blood samples for resting plasma concentrations of cortisol, human growth hormone, prolactin, glucose and C-reactive protein determination, will be collected at 9 AM on the day prior to surgery, intraoperatively (just before termination of pneumoperitoneum) and on the first postoperative day. Furthermore, intraoperative hemodynamic data will be recorded on seven predefined time points: following anesthesia induction, during institution of CO2 pneumoperitoneum, 15 minutes, 30 minutes, 45 minutes and termination of pneumoperitoneum and end of surgical procedure.

Sponsors

Georgia Tsaousi
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients scheduled to undergo elective laparoscopic cholecystectomy for uncomplicated symptomatic cholelithiasis, will be eligible for inclusion.

Exclusion criteria

Exclusion criteria are age < 18 years, ASA physical status > 2, body mass index more than 35 kg/m2, a history of spinal cord surgery, pre-existing coagulation disorders, any medication or organ failure known to interact with stress hormones and sensitivity reactions to amide local anesthetics.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026