Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis

NCT ID: NCT02415335

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Suspected Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Isotonic NaCl

Intervention Type: DRUG

Intravenously administration minimum of 30 minutes preoperatively

dexamethasone

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

Group Type: EXPERIMENTAL

dexamethasone phosphate

Intervention Type: DRUG

Intravenously administration minimum of 30 minutes preoperatively.

Interventions

dexamethasone phosphate

Intravenously administration minimum of 30 minutes preoperatively.

Intervention Type: DRUG

Isotonic NaCl

Intravenously administration minimum of 30 minutes preoperatively

Intervention Type: DRUG

Other Intervention Names

Dexamethasone; Placebo

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jakob Kleif, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Locations

Kirurgisk afdeling, Nordsjællands Hospital

Hillerød, , Denmark

Kirurgisk afdeling, Køge sygehus

Køge, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29605019 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28072446 (View on PubMed)

Other Identifiers

2014-005040-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014-707

Identifier Type: -

Identifier Source: org_study_id