Vascular response in leg and arm muscles to injection of spinal analgesic in addition to general anaesthesia during laparoscopic gynecologic surgery

• Register: ISRCTN
• Last refreshed on: 18 May 2020
• Main ID: ISRCTN49716637
• Date of registration: 05/01/2018
• Prospective Registration: Yes
• Primary sponsor: University Medical Centre Maribor
• Public title: Vascular response in leg and arm muscles to injection of spinal analgesic in addition to general anaesthesia during laparoscopic gynecologic surgery
• Scientific title: Influence of spinal analgesia as addition to general anesthesia for laparoscopic gynecologic surgery on microvascular reactivity in musculus brachioradialis and musculus triceps surae
• Date of first enrolment: 08/01/2018
• Target sample size: 102
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN49716637
• Study type: Interventional
• Study design: Single-centre prospective randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Slovenia

Contacts

• Name: Marko Zdravkovic

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Planned laparoscopic gynecologic surgery with duration of pneumoperitoneum of at least 20 minutes
Surgery

Intervention(s)

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 the group assignments (in 1:1:1 ratio) in sequentially numbered opaque envelopes. Each envelope will be later opened by the principal investigator after the patient’s consented enrolment and after placing the patients name sticker on the envelope.

The three groups are:
Group GA: General anaesthesia alone (control group)
Group GA+SA1: General anaesthesia combined with spinal analgesia with 3.75 mg of levobupivacaine and 2.5 mcg of sufentanil (volume: 2mL)
Group GA+SA2: General anaesthesia combined with spinal analgesia with 7.5 mg of levobupivacaine and 2.5 mcg of sufentanil (volume: 2mL)

All participants will be premedicated with midazolam one hour before surgery which is titrated according to their weight. After entrance to the operating theatre the standard anaesthesia monitoring will be applied and the first venous blood sample taken. Additionally for assessing microvascular reactivity in left m. brachioradialis and right m. triceps surae, pressure cuffs will be attached proximally to NIRS (Near Infra-Red Spectroscopy) electrodes over the corresponding muscles.

In the control group (Group GA), the first vascular occlusion test will be performed on the left arm and right leg by inflating the pressure cuffs to 30mmHg over the patients systolic blood pressure in 4 seconds. After 3 minutes the cuffs will be quickly released (in 2 seconds).

In the intervention groups (GA+SA1 and GA+SA2) the corresponding (hypobaric) spinal analgesic dose will b

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

KME 0120-603/2017/5

Source(s) of Monetary Support

University Medical Centre Maribor

Ethics review

Status:
Approval date:
Contact:

Republic of Slovenia National Medical Ethics Committee - NMEC, 14/12/2017, ref: 0120-603/2017/5

Results

• Results available: Yes
• Date Completed: 31/12/2020