Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

Vaginal Hysterectomy Clinical Trial

Official title:

Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia : Impact on Block Characteristics, on Acute and Chronic Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883347
• Other study ID #: 107/13-02-2019
• Status: Recruiting
• Phase: Phase 3
• Start date: March 20, 2019
• Est. completion date: April 20, 2022

Study information

• Verified date: October 2019
• Source: University of Athens
• Contact: Panagiota Brattou
• Phone: +306957786459
• Email: brattoup[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Suburethral Slings
• Vaginal Hysterectomy

Intervention

Drug:
• Dexmedetomidine
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
• Remifentanil
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

Locations

Country	Name	City	State
Greece	Aretaieio Hospital, University of Athens	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	6 months
Other	Adverse effects	Adverse effects of drugs, anaesthetic or surgical technique and any intraoperative adverse events	24 hours postoperatively
Other	Sedation	Ramsay sedation scale ( 1:anxious, agitated or restless- 6: asleep, no response )	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Other	Postoperative need of rescue analgesia	Consumption of paracetamol	24 hours postoperatively
Other	Patient satisfaction over anaesthesia	scale for satisfaction (0:no satisfaction at all, 10:satisfaction)	24 hours postoperatively
Other	Nausea	Scale for nausea (0:no nausea 10:worst possible nausea)	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Other	Vomiting	Number of vomits	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Other	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
Other	Sensory blockade	Time for onset of sensory block at T10 and to maximum sensory block	30 minutes
Other	Motor blockade	Time to bromage 2 and to bromage 3	30 minutes
Other	Highest level of sensory block	dermatome	30 minutes
Other	Sensory Regression	Time to two segment regression	240 minutes
Other	Motor block regression	time to bromage 1 and bromage 0	240 minutes
Other	Time to max effect (Tmax)	Time when the motor blockade is complete and sensory blockade is in the highest dermatome	30 minutes
Primary	Duration of postoperative analgesia	Time for first analgesia / PCA first bolus	24 hours postoperatively
Secondary	Analgesic consumption	Morphine consumption in mg	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively