Planned laparoscopic gynecologic surgery with duration of pneumoperitoneum of at least 20 minutes Surgery
Conditions
Interventions
Participants in the study will be randomly allocated to one of three groups based on computer generated list of random numbers by a non-investigator who also concealed the group allocation by putting
Sponsors
University Medical Centre Maribor
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years 2. ASA Physical Status I or II 3. Planned laparoscopic gynecologic surgery with duration of pneumoperitoneum of at least 20 minutes
Exclusion criteria
Exclusion criteria: 1. Allergy or sensitivity to any medication used in trial 2. Alcohol or drug abuse 3. Body mass index higher than 35 kg/m2 or lower than 15 kg/m2 4. Pregnancy or breastfeeding status 5. Diabetic patients on insulin treatment 6. Untreated arterial hypertension 7. Peripheral arterial disease 8. Corticosteroid treatment 9. Coagulopathy or other contraindication for spinal analgesia 10. Known difficult airway management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Microvascular reactivity in selected muscles (i.e. microhemodynamics): desaturation/resaturation rates in NIRS (measured by INVOS system) during/after vascular occlusion tests (before general anaesthesia, 5 minutes after intubation, 15 minutes after pneumoperitoneum) 2. Standard macrohemodynamic parameters (blood pressure measured non-invasively by arm cuff and heart rate measured by ECG) correlation with desaturation/resaturation rates in NIRS (measured by INVOS system) during/after vascular occlusion tests (before general anaesthesia, 5 minutes after intubation, 15 minutes after pneumoperitoneum) 3. Upper vs lower body desaturation/resaturation rates in NIRS (measured by INVOS system) during/after vascular occlusion tests (before general anaesthesia, 5 minutes after intubation, 15 minutes after pneumoperitoneum) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other NIRS (measured by INVOS system) parameters: minimal tissue saturation, maximal tissue saturation and rate of return to baseline during/after vascular occlusion tests (before general anaesthesia, 5 minutes after intubation, 15 minutes after pneumoperitoneum) 2. Surgical stress response as assessed by stress hormone levels in venous blood samples taken at baseline and after the last vascular occlusion test 3. Postoperative pain (measured by Visual Analogue Scale at rest and during coughing) and analgesic consumption at 30 minutes, 1 hour, 2 hours, 4. hours and 24 hours after extubation 4. Sevoflurane consumption per minute between the the second and third vascular occlusion test 5. Vasoactive drugs and fluids consumption by the end of the last vascular occlusion test and during the whole surgery 6. Blood pressure measured non-invasively by arm cuff and heart rate measured by ECG and peripheral saturation at the three designated measurement points (before general anaesthesia, 5 minutes after intubation, 15 minutes after pneumoperitoneum) 7. Potential rescue managements during the study protocol and within the duration of surgery 8. Patient satisfaction collected via anonymous questionnaire 24 hours after the surgery | — |
Countries
Slovenia
Outcome results
None listed