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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group DEX | Active Comparator | Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.6 mcg / kg / h. |
|
| Group REMI | Active Comparator | Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.025 mcg / kg / min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative analgesia | Time for first analgesia / PCA first bolus | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic consumption | Morphine consumption in mg | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Numerical Rating Scale (NRS scale) (0:no pain 10:worst pain ever) | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively |
| Chronic pain | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Panagiota Brattou | Contact | +306957786459 | brattoup@gmail.com | |
| Chryssoula Staikou | Contact | +306932352742 | c_staikou@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Cryssoula Staikou | Aretaieio Hospital Medical School University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aretaieio Hospital, University of Athens | Recruiting | Athens | Attica | 11528 | Greece |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
|
| Remifentanil | Drug | 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 |
|
|
| 6 months |
| Adverse effects | Adverse effects of drugs, anaesthetic or surgical technique and any intraoperative adverse events | 24 hours postoperatively |
| Sedation | Ramsay sedation scale ( 1:anxious, agitated or restless- 6: asleep, no response ) | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively |
| Postoperative need of rescue analgesia | Consumption of paracetamol | 24 hours postoperatively |
| Patient satisfaction over anaesthesia | scale for satisfaction (0:no satisfaction at all, 10:satisfaction) | 24 hours postoperatively |
| Nausea | Scale for nausea (0:no nausea 10:worst possible nausea) | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively |
| Vomiting | Number of vomits | 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively |
| Sedation | Ramsay sedation scale(1:anxious, agitated or restless- 6: asleep, no response) | Baseline (before start of infusion), at 5 minutes load, end of 10 minutes load, at spinal time, every 5 minutes until 30 minutes, every 10 minutes until the end of the surgery |
| Sensory blockade | Time for onset of sensory block at T10 and to maximum sensory block | 30 minutes |
| Motor blockade | Time to bromage 2 and to bromage 3 | 30 minutes |
| Highest level of sensory block | dermatome | 30 minutes |
| Sensory Regression | Time to two segment regression | 240 minutes |
| Motor block regression | time to bromage 1 and bromage 0 | 240 minutes |
| Time to max effect (Tmax) | Time when the motor blockade is complete and sensory blockade is in the highest dermatome | 30 minutes |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |