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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001135606
• Date of registration: 27/10/2014
• Prospective Registration: No
• Primary sponsor: Georgia Tsaousi
• Public title: The impact of general anesthesia applied alone or with epidural anesthesia on stress response caused by laparoscopic cholecystectomy, using hormonal, metabolic and inflammatory markers.
• Scientific title: 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.
• Date of first enrolment: 15/04/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001135606.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial;
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: A/Prof Georgia Tsaousi

• Name: A/Prof Georgia Tsaousi

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Surgical stress response to laparoscopic cholecystectomy;Cholelithiasis;
Surgical stress response to laparoscopic cholecystectomy
Cholelithiasis

Surgery - Other surgery

Anaesthesiology - Other anaesthesiology

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention(s)

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.

Primary Outcome(s)

Hemodynamic variables such as heart rate and mean arterial blood pressure will also be recorded intraoperatively. Heart rate will be assessed by ECG recording and mean arterial pressure will be recorded by direct arterial pressure monitoring.[Intraoperative hemodynamic data including heart rate and mean arterial pressure, will also be recorded on seven predefined time points: following anesthesia induction (time point 1), during institution of CO2 pneumoperitoneum, 15 minutes, 22 minutes, 30 minutes, 45 minutes and termination of pneumoperitoneum (time points 2, 3, 4, 5 and 6) and end of surgical procedure (time point 7).
]

Surgical stress response.
Blood samples for stress hormones determination, will be kept on ice (4 degrees Celsious), until centrifugation at 1000 g for 15 minutes within 30 minutes of collection and thereafter, the serum will be separated and stored at -30 degrees Celcius until further analyzed with radioanosometric method. PRL and GH will be analyzed by a solid-phase, two-site chemiluminescent immunometric assay with a detection limit of 1.9 to 25 ng/ml and 0.06 to 5 ng/ml, respectively. Solid-phase, competitive chemiluminescent enzyme immunoassay will be used for detection of COR with morning normal values range between 5 to 20 microg/dL. Plasma glucose levels will be determined by a glucose oxydase method, while serum concentration of CRP will be measured by an immunoprecipitation method.
[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 (baseline), intraoperatively (just before termination of pneumoperitoneum) and on the first
postoperative day.
]

Secondary Outcome(s)

Postoperative analgesic efficacy will be graded with a 10 cm Visual Analogue Scale.[Visual Analogue Scale will be assessed at rest on postoperative hours 1, 6 and 24.]

Secondary ID(s)

None

Source(s) of Monetary Support

Georgia Tsaousi

Secondary Sponsor(s)

Irini Sidiropoulou

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committe of Ahilopouleio General Hospital