NCT03110653

Brief Summary

Modern anesthesia has made a lot of progress, however, postoperative pain remains one of the major problems associated with patient discomfort, prolonged hospital stay and increased health care costs. Remifentanil is an ultra-short-acting phenylpiperidine opioid analgesic with high lipid solubility and a rapid onset of effect. Recently, opioid use has also been associated with postoperative opioid-induced hyperalgesia or acute opioid tolerance. An immediate discontinuation of remifentanil has been associated to increased postoperative pain levels. We would like to investigate whether a gradual post-operative withdrawal of remifentanil is indeed associated with less immediate pain compared to after an abrupt withdrawal in surgical patients undergoing minor surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

March 31, 2017

Last Update Submit

October 16, 2017

Conditions

AnesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • First demand of postoperative analgesic

    the first demand of post-operative analgesic will be compared in both groups.

    24 hours postoperative

Secondary Outcomes (2)

  • Pain evaluation

    24 hours postoperative

  • Patient satisfaction

    24 hours postoperative

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Remifentanil TCI: gradual withdrawal: reduction of 30% / 15 mins (2 -\> 1.4 -\> 1 -\> 0.7-\> 0.5 -\> 0.35 -\> 0.25 -\> 0 ng/ml)

Drug: Remifentanil

NaCl 0.9%

PLACEBO COMPARATOR

Remifentanil abrupt discontinuation / NaCl 0.9% (control group with a reduction of 30% /15 mins) (2 -\> 1.4 -\> 1 -\> 0.7-\> 0.5 -\> 0.35 -\> 0.25 -\> 0 ng/ml)

Drug: NaCl 0.9%

Interventions

RemifentanilDRUG

Remifentanil will be continued postoperatively, while being decreased (gradually by 30% every 15 mins)

Also known as: ultiva
Remifentanil
NaCl 0.9%DRUG

NaCl 0.9% will be administered postoperatively, while being decreased by 30% every 15 mins.

Also known as: physiological serum
NaCl 0.9%

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing a thyroid surgery
  • male/female
  • from the age of 18 until 65
  • ASA physical status of I-III
  • Knowledge of French, English or Dutch is required in order to be enrolled in this study.

You may not qualify if:

  • Pregnancy
  • hypo-/hyperthyroidism
  • gastro-duodenal ulcer
  • allergy or contraindications to one of the study drugs
  • renal insufficiency
  • liver insufficiency
  • neuropsychiatric disturbance
  • BMI \>30
  • history of drug and alcohol abuse
  • preoperative analgesic drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (1)

  • Saxena S, Gonsette K, Terram W, Huybrechts I, Nahrwold DA, Cappello M, Barvais L, Engelman E. Gradual withdrawal of remifentanil delays initial post-operative analgesic demand after thyroid surgery; double-blinded, randomized controlled trial. BMC Anesthesiol. 2019 Apr 25;19(1):60. doi: 10.1186/s12871-019-0731-9.

    PMID: 31027480DERIVED

MeSH Terms

Conditions

Pain

Interventions

RemifentanilSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Luc Barvais

    Erasme Hospital, Brussels

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patients, the anesthesiologist and an external observer will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 12, 2017

Study Start

April 15, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

BE(1)