The effect of epidural anaesthesia on systemic and local blood flow during stomach cancer operation

The effect of epidural anaesthesia on systemic and splanchnic hemodynamic during gastroesophageal resections, a randomized controlled trial - The effect of epidural anaesthesia on blood flow

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002036-14-DK

Enrollment

Unknown

Registered

2014-06-16

Start date

2014-08-08

Completion date

Unknown

Last updated

2017-01-09

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

Conditions

The effect of epidural anaesthesia on systemic and splanchnic hemodynamic during gastroesophageal cancer resection MedDRA version: 17.0 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction System Organ Class: 100000004864

Interventions

Trade Name: Lidokain-adrenalin SAD. Pharmaceutical Form: Solution for injection INN or Proposed INN: LIDOCAINE HYDROCHLORIDE Other descriptive name: lidocain Concentration unit: mg/ml milligram(s)/mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patiens over 18 years of age planned for gastroesophageal resection due to adenocarcinoma of the gastroesophageal junction. No discriminations of ethnic or gender. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Lack of consent. Patients planned for robot-assisted surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: Epidural anaesthesia reduces the sympathetic response, thereby possibly inhibiting the microcirculation in the splanchnic system, especially in the gastric conduit. With this study, we wish to evaluate hemodynamic fluctuations and gastric circulation as well as vasodilatory substances (e.g. PGI2) in relevant intervals from the activation of epidural analgesia. The hypothesis is that epidural analgesia reduces sympathetic nerve activity and thereby inhibiting the splanhcnic microcirculation, especially in the gastric conduit. Late activation of epidural analgesia is believed to be more advantageous.;Secondary Objective: The secondary objective is to investigate the surgical stress response during and after surgery and the rate of postoperative complications, such as anstomotic leakage, infections, and pulmonary complications, in relation with early or late activation of epidural anaesthesia. ;Primary end point(s): Significant alterations in microcirculation in the gastric conduit related to early versus late activation of epidural anaesthesia. The study will be stopped when 50 patients have been randomised to early or late activation af epidural anaesthesia during surgery. ;Timepoint(s) of evaluation of this end point: The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.	—

Measure

Time frame

Main Objective: Epidural anaesthesia reduces the sympathetic response, thereby possibly inhibiting the microcirculation in the splanchnic system, especially in the gastric conduit. With this study, we wish to evaluate hemodynamic fluctuations and gastric circulation as well as vasodilatory substances (e.g. PGI2) in relevant intervals from the activation of epidural analgesia. The hypothesis is that epidural analgesia reduces sympathetic nerve activity and thereby inhibiting the splanhcnic microcirculation, especially in the gastric conduit. Late activation of epidural analgesia is believed to be more advantageous.;Secondary Objective: The secondary objective is to investigate the surgical stress response during and after surgery and the rate of postoperative complications, such as anstomotic leakage, infections, and pulmonary complications, in relation with early or late activation of epidural anaesthesia. ;Primary end point(s): Significant alterations in microcirculation in the gastric conduit related to early versus late activation of epidural anaesthesia. The study will be stopped when 50 patients have been randomised to early or late activation af epidural anaesthesia during surgery. ;Timepoint(s) of evaluation of this end point: The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.

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Secondary

Measure	Time frame
Secondary end point(s): Significant differences of intra- and postoperative levels of surgical response between the groups, defined as alterations in serum cortisol, aldosterone, adrenaline, noradrenaline, and ACTH. Significant alterations in the plasmalevels og atrial natriuretic hormon (ANP), prostacyclin and GLP-1 Significant differences in the rate of postoperative complications between the groups, such as anastomotic leakage, infections, pulmonary complications, and death. ;Timepoint(s) of evaluation of this end point: The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.	—

Measure

Time frame

Secondary end point(s): Significant differences of intra- and postoperative levels of surgical response between the groups, defined as alterations in serum cortisol, aldosterone, adrenaline, noradrenaline, and ACTH. Significant alterations in the plasmalevels og atrial natriuretic hormon (ANP), prostacyclin and GLP-1 Significant differences in the rate of postoperative complications between the groups, such as anastomotic leakage, infections, pulmonary complications, and death. ;Timepoint(s) of evaluation of this end point: The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.

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Countries

Denmark

Contacts

Public ContactRikard Bien Ambrus

Department of Surgical Gastroenterology, Rigshospitalet

rikard.bien.ambrus.02@regionh.dk004560677929

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026