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Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis

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ClinicalTrials.gov Identifier: NCT02415335
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Zealand University Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital

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.

Condition or disease Intervention/treatment Phase
Suspected Appendicitis Drug: dexamethasone phosphate Drug: Isotonic NaCl Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis
Study Start Date : April 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


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 Name: 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 Name: Dexamethasone




Primary Outcome Measures :
  1. Postoperative nausea and vomiting (PONV) [ Time Frame: 24-32 hours postoperative ]
    Incidents of nausea and/or vomiting during the first 24-32 hours postoperative


Secondary Outcome Measures :
  1. Pain at rest (VAS scale) [ Time Frame: 2-10 hours postoperative ]
    Pain at rest measured on a 100 mm VAS scale

  2. Pain when coughing (VAS scale) [ Time Frame: 2-10 hours postoperative ]
    Pain when coughing measured on a 100 mm VAS scale

  3. Postoperative fatigue (VAS scale) [ Time Frame: 2-10 hours postoperative ]
    Postoperative fatigue measured on a 100 mm VAS scale

  4. Quality of recovery (QoR-15D questionnaire) [ Time Frame: 24-32 hours postoperative ]
    Quality of recovery measured by the QoR-15D questionnaire

  5. Time until resumption of normal daily activities [ Time Frame: Registration when resumption, expected to be within 60 days postoperatively ]
    Time until resumption of normal daily activities and reason for not resuming activities earlier

  6. Time until resumption of work [ Time Frame: Registration when resumption, expected to be within 60 days postoperatively ]
    Time until resumption of work and reason for not resuming work earlier

  7. Sleep quality (VAS scale) [ Time Frame: 24-32 hours postoperative ]
    Quality of sleep measured on a 100 mm VAS scale

  8. Postoperative complications (Clavien-Dindo classification of surgical complications) [ Time Frame: 30 days postoperative ]
    30 days postoperative complication according to the Clavien-Dindo classification of surgical complications

  9. Duration of admission [ Time Frame: 30 days ]
    Duration of primary admission

  10. PONV [ Time Frame: 2-10 hours postoperatively ]
  11. PONV [ Time Frame: 8-16 hours postoperatively ]
  12. PONV [ Time Frame: 24-32 hours postoperatively ]
  13. Pain at rest (VAS scale) [ Time Frame: 8-16 hours postoperative ]
    Pain at rest measured on a 100 mm VAS scale

  14. Pain at rest (VAS scale) [ Time Frame: 24-32 hours postoperative ]
    Pain at rest measured on a 100 mm VAS scale

  15. Pain at rest (VAS scale) [ Time Frame: POD (Post Operative Day) 2 ]
    Pain at rest measured on a 100 mm VAS scale

  16. Pain at rest (VAS scale) [ Time Frame: POD3 ]
    Pain at rest measured on a 100 mm VAS scale

  17. Pain at rest (VAS scale) [ Time Frame: POD7 ]
    Pain at rest measured on a 100 mm VAS scale

  18. Pain at rest (VAS scale) [ Time Frame: POD14 ]
    Pain at rest measured on a 100 mm VAS scale

  19. Pain at rest (VAS scale) [ Time Frame: POD30 ]
    Pain at rest measured on a 100 mm VAS scale

  20. Pain when coughing (VAS scale) [ Time Frame: 8-16 hours postoperative ]
    Pain when coughing measured on a 100 mm VAS scale

  21. Pain when coughing (VAS scale) [ Time Frame: 24-42 hours postoperative ]
    Pain when coughing measured on a 100 mm VAS scale

  22. Pain when coughing (VAS scale) [ Time Frame: POD2 ]
    Pain when coughing measured on a 100 mm VAS scale

  23. Pain when coughing (VAS scale) [ Time Frame: POD3 ]
    Pain when coughing measured on a 100 mm VAS scale

  24. Pain when coughing (VAS scale) [ Time Frame: POD7 ]
    Pain when coughing measured on a 100 mm VAS scale

  25. Pain when coughing (VAS scale) [ Time Frame: POD14 ]
    Pain when coughing measured on a 100 mm VAS scale

  26. Pain when coughing (VAS scale) [ Time Frame: POD30 ]
    Pain when coughing measured on a 100 mm VAS scale

  27. Postoperative fatigue (VAS scale) [ Time Frame: 8-16 hours postoperative ]
    Postoperative fatigue measured on a 100 mm VAS scale

  28. Postoperative fatigue (VAS scale [ Time Frame: 24-32 hours postoperative ]
    Postoperative fatigue measured on a 100 mm VAS scale

  29. Postoperative fatigue (VAS scale [ Time Frame: POD2 ]
    Postoperative fatigue measured on a 100 mm VAS scale

  30. Postoperative fatigue (VAS scale [ Time Frame: POD3 ]
    Postoperative fatigue measured on a 100 mm VAS scale

  31. Postoperative fatigue (VAS scale [ Time Frame: POD7 ]
    Postoperative fatigue measured on a 100 mm VAS scale

  32. Postoperative fatigue (VAS scale [ Time Frame: POD14 ]
    Postoperative fatigue measured on a 100 mm VAS scale

  33. Postoperative fatigue (VAS scale [ Time Frame: POD30 ]
    Postoperative fatigue measured on a 100 mm VAS scale

  34. Quality of recovery (QoR-15D questionnaire) [ Time Frame: POD2 ]
    Quality of recovery measured by the QoR-15D questionnaire

  35. Quality of recovery (QoR-15D questionnaire) [ Time Frame: POD3 ]
    Quality of recovery measured by the QoR-15D questionnaire

  36. Quality of recovery (QoR-15D questionnaire) [ Time Frame: POD7 ]
    Quality of recovery measured by the QoR-15D questionnaire

  37. Quality of recovery (QoR-15D questionnaire) [ Time Frame: POD14 ]
    Quality of recovery measured by the QoR-15D questionnaire

  38. Quality of recovery (QoR-15D questionnaire) [ Time Frame: POD30 ]
    Quality of recovery measured by the QoR-15D questionnaire

  39. Sleep quality (VAS scale) [ Time Frame: POD2 ]
    Quality of sleep measured on a 100 mm VAS scale

  40. Sleep quality (VAS scale) [ Time Frame: POD3 ]
    Quality of sleep measured on a 100 mm VAS scale

  41. Sleep quality (VAS scale) [ Time Frame: POD7 ]
    Quality of sleep measured on a 100 mm VAS scale

  42. Sleep quality (VAS scale) [ Time Frame: POD14 ]
    Quality of sleep measured on a 100 mm VAS scale

  43. Sleep quality (VAS scale) [ Time Frame: POD30 ]
    Quality of sleep measured on a 100 mm VAS scale


Other Outcome Measures:
  1. Mobilisation postoperative (Ability to get out of bed) [ Time Frame: 2-10 hours postoperative ]
    Ability to get out of bed

  2. Pain localization (Localization of postoperative pain) [ Time Frame: 2-10 hours postoperative ]
    Localization of postoperative pain

  3. Adverse events [ Time Frame: 30 days ]
    AE, AR, SAR and SUSARS

  4. Mobilisation postoperative (Ability to get out of bed) [ Time Frame: 8-16 hours postoperative ]
    Ability to get out of bed

  5. Mobilisation postoperative (Ability to get out of bed) [ Time Frame: 24-32 hours postoperative ]
    Ability to get out of bed

  6. Pain localization (Localization of postoperative pain) [ Time Frame: 8-16 hours postoperative ]
    Localization of postoperative pain

  7. Pain localization (Localization of postoperative pain) [ Time Frame: 24-32 hours postoperative ]
    Localization of postoperative pain

  8. Pain localization (Localization of postoperative pain) [ Time Frame: POD2 ]
    Localization of postoperative pain

  9. Pain localization (Localization of postoperative pain) [ Time Frame: POD3 ]
    Localization of postoperative pain

  10. Pain localization (Localization of postoperative pain) [ Time Frame: POD7 ]
    Localization of postoperative pain

  11. Pain localization (Localization of postoperative pain) [ Time Frame: POD14 ]
    Localization of postoperative pain

  12. Pain localization (Localization of postoperative pain) [ Time Frame: POD30 ]
    Localization of postoperative pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415335


Locations
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Denmark
Kirurgisk afdeling, Nordsjællands Hospital
Hillerød, Denmark, 3400
Kirurgisk afdeling, Køge sygehus
Køge, Denmark, 4600
Sponsors and Collaborators
Nordsjaellands Hospital
Zealand University Hospital
Investigators
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Principal Investigator: Jakob Kleif, M.D. Nordsjaellands Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02415335     History of Changes
Other Study ID Numbers: 2014-707
2014-005040-18 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action