Suburethral Slings, Vaginal Hysterectomy
Conditions
Brief summary
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.
Detailed description
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include ECG, noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). A peripheral intravenous catheter wil be placed for fluid replacement ( Ringer's Lactate solution 6 - 8ml/ kg/hr) and administration of drugs. Women will be randomly assigned into one of two groups: Group A: Women will receive dexmedetomidine continuously infused at a dose of 0,6 mcg/kg for 10 minutes (concentration of the solution 6mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia. Group B: Women will receive remifentanil continuously infused at a dose of 1mcg/kg for 10 minutes (concentration of the solution 1mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia. The insertion of a 27 Gauge (27G) spinal needle is performed at L3-L4 or L4-L5 interspace, in the lateral position. All patients will receive 2,7 ml ropivacaine 0,75% and 15 mcg fentanyl intrathecally and assessment of sensory and motor block will be assessed every 2 min. The moment that sensory block is in the highest dermatome and motor block is complete (Bromage grade 3) is Time to max effect (Tmax). In group A an infusion of dexmedetomidine (6mcg/ml) at a dose of 0,6mcg/kg/hr will be administered and in group B an infusion of remifentanil (1mcg/ml) at a dose of 0,03 mcg/kg/min.At the end of the surgery patients will be transferred in Post Anaesthetic Care Unit (PACU) and a patient control analgesia (PCA) pump will be provided to the patient, administering 1 mg of morphine in every attempt, with a lock out interval of 10 minutes.There will be no continuous infusion. All patients will receive a standardized multimodal approach, including diclofenac 50 mg t.i.d, paracetamol 1gr as rescue analgesia (max 4 gr per day) and PCA with morphine.
Interventions
DRUGDexmedetomidine
Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia and 0.6 mcg / kg / h after performing regional anaesthesia until the end of the surgery
DRUGRemifentanil
Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia and 0.025 mcg / kg / h after performing regional anaesthesia until the end of the surgery
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All syringes and solutions will be prepared by an independent researcher who will not be further involved in the study eg data collecting or analyzing them.All syringes will look identical to the anesthetist who will administer them to the patients.Apart from the anesthetist, the surgery staff and the researchers recording the measurements will not know the therapeutic intervention team in which each patient has been randomized.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Physical status according to American Society of Anesthesiologists (ASA) I-II * Patients scheduled for transvaginal urogynecological or gynecological surgery
Exclusion criteria
* Patient refusal * Contraindication of spinal anaesthesia (Coagulopathy, Local infection at the site of injection, Local anaesthetic allergy, Hypovolaemia) * BMI \> 30 kg/m2 * Personal history of cardiovascular disease * Arrythmias * Conduction disorders * Severe kidney or liver dysfunction * Insulin-dependent diabetes mellitus * Central nervous system disorders * Psychiatric and mental status disorders * Chronic Excessive Alcohol Consumption * Chronic Use of Opioid Analgesics * Chronic Use of corticosteroids * Chronic Use of clonidine (or other a2 adrenergic agonist) * Use of drugs acting on central nervous system or analgetics the last two weeks * Communication problems due to language barriers or unable to understand the pain scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative analgesia | 24 hours postoperatively | Time for first analgesia / PCA first bolus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic consumption | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively | Morphine consumption in mg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Motor block regression | 240 minutes | time to bromage 1 and bromage 0 |
| Postoperative pain | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively | Numerical Rating Scale (NRS scale) (0:no pain 10:worst pain ever) |
| Chronic pain | 6 months | Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting |
| Adverse effects | 24 hours postoperatively | Adverse effects of drugs, anaesthetic or surgical technique and any intraoperative adverse events |
| Sedation | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively | Ramsay sedation scale ( 1:anxious, agitated or restless- 6: asleep, no response ) |
| Postoperative need of rescue analgesia | 24 hours postoperatively | Consumption of paracetamol |
| Patient satisfaction over anaesthesia | 24 hours postoperatively | scale for satisfaction (0:no satisfaction at all, 10:satisfaction) |
| Nausea | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively | Scale for nausea (0:no nausea 10:worst possible nausea) |
| Vomiting | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively | Number of vomits |
| Sensory blockade | 30 minutes | Time for onset of sensory block at T10 and to maximum sensory block |
| Motor blockade | 30 minutes | Time to bromage 2 and to bromage 3 |
| Highest level of sensory block | 30 minutes | dermatome |
| Time to max effect (Tmax) | 30 minutes | Time when the motor blockade is complete and sensory blockade is in the highest dermatome |
| Sensory Regression | 240 minutes | Time to two segment regression |
Countries
Greece
Contacts
Primary ContactPanagiota Brattou
Backup ContactChryssoula Staikou
Outcome results
None listed