Clinical trial NCT02415335: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Official title: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Suspected Appendicitis
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2015-04-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Eligible patients undergoing a diagnostic laparoscopy for suspected appendicitis will be randomized to receive placebo or 8 mg dexamethasone intravenously minimum 30 minutes prior to the operation.

Randomization will be done by envelope randomization. We would expect that 60% of the patients would experience postoperative nausea or vomiting (PONV) during the first 24-32 hours postoperatively. To show a 50% reduction in the incidents of PONV during the first 24-32 hours postoperatively (with a power of 80%, a significant level of 5% and a loss to follow up of 20%) we need 60 patients in each arm. So a total of 120 patients are to be randomized 1:1.

Both sites use paper Case Report Forms (CRF). The trial will be monitored by the regional GCP (Good Clinical Practice) unit and adhere to GCP guidelines.

Patients are assessed by self reporting questionnaires preoperatively and postoperatively after 2-10 hours, 8-16 hours, 24-32 hours, on postoperative day (POD) 2, POD 3, POD 7, POD 14 and POD 30.

Preoperative anxiety recorded by a VAS scale, Pain Catastrophizing Scale and Hospital anxiety and depression scale are recorded by the preoperative questionnaire.

A short telephone interview will be done during the first postoperative day regarding duration of abdominal pain prior to admission, social status regarding children and whether they living with another adult, smoking status, use of sleep medication or use of psychopharmacy a minimum of 7 days prior to the operation, physical level of normal daily activities, physical level of work, educational and occupational background.

Other demographics such as height, weight, ASA class, age, last CRP prior to the operation, duration of the operation, date and time of admission, date and time of discharge are registered through the electronic patient record files. Pathology of any removed tissue are registered trough the pathology report.

Diagnosis at the operation, preformed procedure, whether the preforming surgeon was supervised, number of identical procedures preformed previous by the surgeon or the surgeons supervisor (if supervised) will be recorded in the patients CRF by the preforming surgeon.

Pre-, intra- and post-operative pain medication, antiemetics and antibiotics are recorded through the electronic patient medication files.

Postoperative complications and adverse events are recorded through the electronic patient record files and by telephone interview.

To ensure a high completion rate, patients are contacted by telephone at each registration time postoperatively.

Parametric or non-parametric statistical analysis will be used when appropriate.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.
* Vaccination within 14 days prior to inclusion.
* Known cushing's disease.
* Known myasthenia gravis.
* Presumably poor compliance with study protocol.

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: 24-32 hours postoperative
Secondary outcomes:
measure: Pain at rest (VAS scale)
timeFrame: 2-10 hours postoperative
measure: Pain when coughing (VAS scale)
timeFrame: 2-10 hours postoperative
measure: Postoperative fatigue (VAS scale)
timeFrame: 2-10 hours postoperative
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: 24-32 hours postoperative
measure: Time until resumption of normal daily activities
timeFrame: Registration when resumption, expected to be within 60 days postoperatively
measure: Time until resumption of work
timeFrame: Registration when resumption, expected to be within 60 days postoperatively
measure: Sleep quality (VAS scale)
timeFrame: 24-32 hours postoperative
measure: Postoperative complications (Clavien-Dindo classification of surgical complications)
timeFrame: 30 days postoperative
measure: Duration of admission
timeFrame: 30 days
measure: PONV
timeFrame: 2-10 hours postoperatively
measure: PONV
timeFrame: 8-16 hours postoperatively
measure: PONV
timeFrame: 24-32 hours postoperatively
measure: Pain at rest (VAS scale)
timeFrame: 8-16 hours postoperative
measure: Pain at rest (VAS scale)
timeFrame: 24-32 hours postoperative
measure: Pain at rest (VAS scale)
timeFrame: POD (Post Operative Day) 2
measure: Pain at rest (VAS scale)
timeFrame: POD3
measure: Pain at rest (VAS scale)
timeFrame: POD7
measure: Pain at rest (VAS scale)
timeFrame: POD14
measure: Pain at rest (VAS scale)
timeFrame: POD30
measure: Pain when coughing (VAS scale)
timeFrame: 8-16 hours postoperative
measure: Pain when coughing (VAS scale)
timeFrame: 24-42 hours postoperative
measure: Pain when coughing (VAS scale)
timeFrame: POD2
measure: Pain when coughing (VAS scale)
timeFrame: POD3
measure: Pain when coughing (VAS scale)
timeFrame: POD7
measure: Pain when coughing (VAS scale)
timeFrame: POD14
measure: Pain when coughing (VAS scale)
timeFrame: POD30
measure: Postoperative fatigue (VAS scale)
timeFrame: 8-16 hours postoperative
measure: Postoperative fatigue (VAS scale
timeFrame: 24-32 hours postoperative
measure: Postoperative fatigue (VAS scale
timeFrame: POD2
measure: Postoperative fatigue (VAS scale
timeFrame: POD3
measure: Postoperative fatigue (VAS scale
timeFrame: POD7
measure: Postoperative fatigue (VAS scale
timeFrame: POD14
measure: Postoperative fatigue (VAS scale
timeFrame: POD30
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: POD2
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: POD3
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: POD7
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: POD14
measure: Quality of recovery (QoR-15D questionnaire)
timeFrame: POD30
measure: Sleep quality (VAS scale)
timeFrame: POD2
measure: Sleep quality (VAS scale)
timeFrame: POD3
measure: Sleep quality (VAS scale)
timeFrame: POD7
measure: Sleep quality (VAS scale)
timeFrame: POD14
measure: Sleep quality (VAS scale)
timeFrame: POD30
Other outcomes:
measure: Mobilisation postoperative (Ability to get out of bed)
timeFrame: 2-10 hours postoperative
measure: Pain localization (Localization of postoperative pain)
timeFrame: 2-10 hours postoperative
measure: Adverse events
timeFrame: 30 days
measure: Mobilisation postoperative (Ability to get out of bed)
timeFrame: 8-16 hours postoperative
measure: Mobilisation postoperative (Ability to get out of bed)
timeFrame: 24-32 hours postoperative
measure: Pain localization (Localization of postoperative pain)
timeFrame: 8-16 hours postoperative
measure: Pain localization (Localization of postoperative pain)
timeFrame: 24-32 hours postoperative
measure: Pain localization (Localization of postoperative pain)
timeFrame: POD2
measure: Pain localization (Localization of postoperative pain)
timeFrame: POD3
measure: Pain localization (Localization of postoperative pain)
timeFrame: POD7
measure: Pain localization (Localization of postoperative pain)
timeFrame: POD14
measure: Pain localization (Localization of postoperative pain)
timeFrame: POD30
Locations:
city: Hillerød
country: Denmark
facility: Kirurgisk afdeling, Nordsjællands Hospital
city: Køge
country: Denmark
facility: Kirurgisk afdeling, Køge sygehus
Study officials:
affiliation: Nordsjaellands Hospital
name: Jakob Kleif, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.