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Clinical Trials/NCT03218306
NCT03218306
Unknown
Not Applicable

Surgical Pleth Index Guided Intraoperative Analgesia Versus Standard Clinical Approach During Desflurane Based General Anesthesia for Thyroidectomy

University of Cagliari1 site in 1 country198 target enrollmentOctober 23, 2017
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ConditionsAnesthesiaPainSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
University of Cagliari
Enrollment
198
Locations
1
Primary Endpoint
Remifentanil consumption
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The study is aimed at confronting a surgical pleth index based protocol for intraoperative analgesia in a desflurane based general anesthesia for thyroidectomy, versus a standard clinical approach. A reduction in analgesic consumption and improvement in hemodynamics are expected.

Registry
clinicaltrials.gov
Start Date
October 23, 2017
End Date
December 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Gabriele Finco

Professor of Anesthesiology and Intensive Care

University of Cagliari

Eligibility Criteria

Inclusion Criteria

  • •18\<age\<80 years
  • •American society of anesthesiology (ASA) physical status I -II
  • •6 hrs fasting

Exclusion Criteria

  • •Arrhythmia or Pacemaker
  • •Central or peripheral nervous system or muscular disease
  • •Drugs active on autonomous nervous system (eg clonidine)
  • •Obesity (BMI \>35)
  • •Chronic Pain
  • •Addictions or central nervous acting drugs use
  • •Hypertension (if not treated)
  • •Connective tissue disease
  • •Pregnancy
  • •Allergy or hypersensitivity to study drugs

Outcomes

Primary Outcomes

Remifentanil consumption

Time Frame: Intraoperative

Cumulative remifentanil consumption throughout surgery

Secondary Outcomes

  • Hemodynamics(intraoperative)
  • Desflurane(intraoperative)
  • Extubation delay(intraoperative)
  • Post-operative analgesia 1(24 hr post operative)
  • Post-operative analgesia 2(24 hr post operative)
  • Adverse reactions(24 hr post operative)
  • Patient satisfaction(24 hr post operative)

Study Sites (1)

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