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Completed

NCT Number: NCT01998217

Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone

Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an effective approach for stone drainage and pain relief, and general or epidural anesthesia has been reported for such procedure. Single infusion of remifentanil has been described in ESWL of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover, single infusion of remifentanil might induce several complications, such as postoperative nausea and vomiting. The investigators attended to investigated whether combination of flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.

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Key information

Conditions

Pancreatic Stone Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged 18-65 years
  • ASA I-II
  • ESWL indication was met

Exclusion criteria

  • patients with hypertension
  • patients compromised in cardiopulmonary function
  • patients undergoing ESWL for the second or more times

Treatment and study plan

Remifentanil

Drug

Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.

Flurbiprofen and remifentanil

Drug

Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.

Primary outcomes

  1. Visual analogue score of pain

    Time frame: During ESWL procedure

Secondary outcomes

  1. Cardiovascular responses including blood pressure and heart rate

    Time frame: During ESWL procedure

Other outcomes

  1. Side effects

    Time frame: within 24 hours after ESWL procedure

    The side effects including postoperative nausea and vomiting, as well as pruritus.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Feb 4, 2015

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.