Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis

Suspected Appendicitis Clinical Trial

Official title:

Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415335
• Other study ID #: 2014-707
• Secondary ID: 2014-005040-18
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2015
• Last updated: February 22, 2016
• Start date: April 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Appendicitis
• Suspected Appendicitis

Intervention

Drug:
• dexamethasone phosphate
Intravenously administration minimum of 30 minutes preoperatively.
• Isotonic NaCl
Intravenously administration minimum of 30 minutes preoperatively

Locations

Country	Name	City	State
Denmark	Kirurgisk afdeling, Nordsjællands Hospital	Hillerød
Denmark	Kirurgisk afdeling, Køge sygehus	Køge

Sponsors (2)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Koege Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	2-10 hours postoperative	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	2-10 hours postoperative	No
Other	Adverse events	AE, AR, SAR and SUSARS	30 days	Yes
Other	Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	8-16 hours postoperative	No
Other	Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	24-32 hours postoperative	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	8-16 hours postoperative	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	24-32 hours postoperative	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD2	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD3	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD7	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD14	No
Other	Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD30	No
Primary	Postoperative nausea and vomiting (PONV)	Incidents of nausea and/or vomiting during the first 24-32 hours postoperative	24-32 hours postoperative	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	2-10 hours postoperative	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	2-10 hours postoperative	No
Secondary	Postoperative fatigue (VAS scale)	Postoperative fatigue measured on a 100 mm VAS scale	2-10 hours postoperative	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	24-32 hours postoperative	No
Secondary	Time until resumption of normal daily activities	Time until resumption of normal daily activities and reason for not resuming activities earlier	Registration when resumption, expected to be within 60 days postoperatively	No
Secondary	Time until resumption of work	Time until resumption of work and reason for not resuming work earlier	Registration when resumption, expected to be within 60 days postoperatively	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	24-32 hours postoperative	No
Secondary	Postoperative complications (Clavien-Dindo classification of surgical complications)	30 days postoperative complication according to the Clavien-Dindo classification of surgical complications	30 days postoperative	Yes
Secondary	Duration of admission	Duration of primary admission	30 days	No
Secondary	PONV		2-10 hours postoperatively	No
Secondary	PONV		8-16 hours postoperatively	No
Secondary	PONV		24-32 hours postoperatively	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	8-16 hours postoperative	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	24-32 hours postoperative	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD (Post Operative Day) 2	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD3	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD7	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD14	No
Secondary	Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD30	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	8-16 hours postoperative	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	24-42 hours postoperative	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD2	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD3	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD7	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD14	No
Secondary	Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD30	No
Secondary	Postoperative fatigue (VAS scale)	Postoperative fatigue measured on a 100 mm VAS scale	8-16 hours postoperative	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	24-32 hours postoperative	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD2	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD3	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD7	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD14	No
Secondary	Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD30	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD2	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD3	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD7	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD14	No
Secondary	Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD30	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD2	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD3	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD7	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD14	No
Secondary	Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD30	No