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Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia

NCT03883347 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-10-14

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Cryssoula Staikou · Aretaieio Hospital Medical School University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2022-03-20
Completion
2022-04-20

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883347 on ClinicalTrials.gov