Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

NCT03883347 | Unknown Phase 3

• 1 other identifier: 107/13-02-2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Hysterectomy; Suburethral Slings

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia

  Time for first analgesia / PCA first bolus

  24 hours postoperatively

Secondary Outcomes (1)

• Analgesic consumption

  0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively

Other Outcomes (15)

• Postoperative pain

  0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively

• Chronic pain

  6 months

• Adverse effects

  24 hours postoperatively

Study Arms (2)

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.

Drug: Dexmedetomidine

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.

Drug: Remifentanil

Interventions

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

Also known as: DEXDOR

Group DEX

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

Also known as: ULTIVA

Group REMI

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status according to American Society of Anesthesiologists (ASA) I-II
• Patients scheduled for transvaginal urogynecological or gynecological surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Cryssoula Staikou

  Aretaieio Hospital Medical School University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panagiota Brattou

CONTACT

+306957786459; brattoup@gmail.com

Chryssoula Staikou

CONTACT

+306932352742; c_staikou@yahoo.gr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: March 20, 2019
• Primary Completion: March 20, 2022
• Study Completion: April 20, 2022
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)