Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

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

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.

Study Overview

• Status: Unknown
• Conditions: Vaginal Hysterectomy; Suburethral Slings
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Remifentanil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Recruiting
      • Aretaieio Hospital, University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group DEX; 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.	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; Other Names: DEXDOR
Active Comparator: Group REMI; 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.	Drug: 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; Other Names: ULTIVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	Time for first analgesia / PCA first bolus	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic consumption	Morphine consumption in mg	0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Principal Investigator: Cryssoula Staikou, Aretaieio Hospital Medical School University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: 107/13-02-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No