Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis

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.

Study Overview

• Status: Completed
• Conditions: Suspected Appendicitis
• Intervention / Treatment: Drug: Isotonic NaCl; Drug: dexamethasone phosphate

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Kirurgisk afdeling, Nordsjællands Hospital
  • Køge, Denmark, 4600
    • Kirurgisk afdeling, Køge sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Injection of 2 ml isotonic NaCl intravenously minimum 30 minutes preoperative.	Drug: Isotonic NaCl; Intravenously administration minimum of 30 minutes preoperatively; Other Names: Placebo
Experimental: dexamethasone; Injection of 2 ml 4 mg/ml dexamethasone phosphate intravenously minimum 30 minutes preoperative.	Drug: dexamethasone phosphate; Intravenously administration minimum of 30 minutes preoperatively.; Other Names: Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting (PONV)	Incidents of nausea and/or vomiting during the first 24-32 hours postoperative	24-32 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	2-10 hours postoperative
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	2-10 hours postoperative
Postoperative fatigue (VAS scale)	Postoperative fatigue measured on a 100 mm VAS scale	2-10 hours postoperative
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	24-32 hours postoperative
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
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
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	24-32 hours postoperative
Postoperative complications (Clavien-Dindo classification of surgical complications)	30 days postoperative complication according to the Clavien-Dindo classification of surgical complications	30 days postoperative
Duration of admission	Duration of primary admission	30 days
PONV		2-10 hours postoperatively
PONV		8-16 hours postoperatively
PONV		24-32 hours postoperatively
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	8-16 hours postoperative
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	24-32 hours postoperative
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD (Post Operative Day) 2
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD3
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD7
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD14
Pain at rest (VAS scale)	Pain at rest measured on a 100 mm VAS scale	POD30
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	8-16 hours postoperative
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	24-42 hours postoperative
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD2
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD3
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD7
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD14
Pain when coughing (VAS scale)	Pain when coughing measured on a 100 mm VAS scale	POD30
Postoperative fatigue (VAS scale)	Postoperative fatigue measured on a 100 mm VAS scale	8-16 hours postoperative
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	24-32 hours postoperative
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD2
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD3
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD7
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD14
Postoperative fatigue (VAS scale	Postoperative fatigue measured on a 100 mm VAS scale	POD30
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD2
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD3
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD7
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD14
Quality of recovery (QoR-15D questionnaire)	Quality of recovery measured by the QoR-15D questionnaire	POD30
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD2
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD3
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD7
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD14
Sleep quality (VAS scale)	Quality of sleep measured on a 100 mm VAS scale	POD30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	2-10 hours postoperative
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	2-10 hours postoperative
Adverse events	AE, AR, SAR and SUSARS	30 days
Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	8-16 hours postoperative
Mobilisation postoperative (Ability to get out of bed)	Ability to get out of bed	24-32 hours postoperative
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	8-16 hours postoperative
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	24-32 hours postoperative
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD2
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD3
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD7
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD14
Pain localization (Localization of postoperative pain)	Localization of postoperative pain	POD30

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Zealand University Hospital
• Investigators: Principal Investigator: Jakob Kleif, M.D., Nordsjaellands Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: 2014-707; 2014-005040-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided