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Completed

NCT Number: NCT01229527

Comparison Between Two Different Dosages of Remifentanil During Colonoscopy

The purpose of this randomized double-blind trial is to define the correct dosage of Remifentanil during operative and diagnostic endoscopic procedures. In particular we want to analyze if the administration of Remifentanil by PCSA (Patient Controlled Sedation and Analgesia) is a good method during colonoscopy, evaluating pain control, discharge time and side effects.

90 patients undergoing colonoscopy will be enrolled.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Patients
  • Diagnostic and Operative Colonoscopy
  • ASA Physical Status I-II

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Remifentanil

Drug

Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.

Meperidine

Drug

Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.

Primary outcomes

  1. Discharge Time, the Time to Reach a Modified Aldrete Score ≥18

    Time frame: > 0 minutes

    Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.

Secondary outcomes

  1. Patient's Satisfaction

    Time frame: After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone

    The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Official study title

Comparison Between Two Different Dosages of Remifentanil Administered by PCSA (Patient Controlled Sedation and Analgesia) and Meperidine During Colonoscopy: A Randomized Double-Blind Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2010
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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