NCT02415335

Brief Summary

For elective abdominal surgery preoperative administration of 8 mg dexamethasone reduces the incidents of postoperative nausea and vomiting (PONV). Whether preoperative administration of 8 mg dexamethasone reduces PONV for patients having acute abdominal surgery has not been established. The investigators wish to see if preoperative administration of 8 mg dexamethasone minimum 30 minutes prior to a diagnostic laparoscopy for suspected appendicitis will reduce the incidents of PONV by 50%. Of secondary interest the investigators want to see if 8 mg dexamethasone preoperative can reduce pain, reduce opioid consumption, postoperative fatigue, duration of time until resumption of work and resumption of normal daily activities, and enhanced the quality of recovery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

March 31, 2015

Last Update Submit

February 22, 2016

Conditions

Suspected Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomiting (PONV)

    Incidents of nausea and/or vomiting during the first 24-32 hours postoperative

    24-32 hours postoperative

Secondary Outcomes (43)

  • Pain at rest (VAS scale)

    2-10 hours postoperative

  • Pain when coughing (VAS scale)

    2-10 hours postoperative

  • Postoperative fatigue (VAS scale)

    2-10 hours postoperative

  • Quality of recovery (QoR-15D questionnaire)

    24-32 hours postoperative

  • Time until resumption of normal daily activities

    Registration when resumption, expected to be within 60 days postoperatively

  • +38 more secondary outcomes

Other Outcomes (12)

  • Mobilisation postoperative (Ability to get out of bed)

    2-10 hours postoperative

  • Pain localization (Localization of postoperative pain)

    2-10 hours postoperative

  • Adverse events

    30 days

  • +9 more other outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Injection of 2 ml isotonic NaCl intravenously minimum 30 minutes preoperative.

Drug: Isotonic NaCl

dexamethasone

EXPERIMENTAL

Injection of 2 ml 4 mg/ml dexamethasone phosphate intravenously minimum 30 minutes preoperative.

Drug: dexamethasone phosphate

Interventions

dexamethasone phosphateDRUG

Intravenously administration minimum of 30 minutes preoperatively.

Also known as: Dexamethasone
dexamethasone
Isotonic NaClDRUG

Intravenously administration minimum of 30 minutes preoperatively

Also known as: Placebo
Placebo

Eligibility Criteria

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

You may qualify if:

  • Scheduled for a diagnostic laparoscopy for suspected appendicitis
  • ASA clas I-III

You may not qualify if:

  • Known inflammatory bowel disease
  • Known autoimmune disease.
  • Chronic pain patient.
  • Pregnant or breastfeeding.
  • In treatment with systemic corticoid steroids or immune-depressants.
  • Known glaucoma.
  • Known ocular herpes simplex.
  • Known cushing's disease.
  • Known myasthenia gravis.
  • Presumably poor compliance with study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kirurgisk afdeling, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Kirurgisk afdeling, Køge sygehus

Køge, 4600, Denmark

Location

Related Publications (2)

  • Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.

    PMID: 29605019DERIVED

  • Kleif J, Kirkegaard A, Vilandt J, Gogenur I. Randomized clinical trial of preoperative dexamethasone on postoperative nausea and vomiting after laparoscopy for suspected appendicitis. Br J Surg. 2017 Mar;104(4):384-392. doi: 10.1002/bjs.10418. Epub 2017 Jan 10.

    PMID: 28072446DERIVED

MeSH Terms

Interventions

dexamethasone 21-phosphateDexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jakob Kleif, M.D.

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

DK(2)