Recovery of stomach function after treatment with strong analgesics.

Phase 1

Conditions: The effect of opioids on gastric electrical activity
MedDRA version: 18.1Level: LLTClassification code 10018043Term: GastroparesisSystem Organ Class: 100000004856
MedDRA version: 18.1Level: PTClassification code 10018044Term: Gastroparesis postoperativeSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 18.1Level: LLTClassification code 10021227Term: Idiopathic gastroparesisSystem Organ Class: 100000004856
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-005489-46-SE

Lead Sponsor: meå University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

ASA-class 1-2
non-smoker
Women and Men Aged 18 - 65 y
Body Mass Index (BMI) 18-30
Research person are able to undergo the study
Signed and dated informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or breastfeeding women
Patophysiologi that affect gastric motility
Medication that affect gastric motility
History of abuse
Other factor that the investigator consider important
Already participated in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to explore gastric recovery after treatment with short-actings opioids.;Secondary Objective: Secondary objectives are to study the effects of opioids on gastric myoelectric activity and evaluation of safety variables.;Primary end point(s): Time to recovery (minutes) of normal gastric electrical activity defined as dominant frequency +/-10% of dominant frequency before opioid administration.;Timepoint(s) of evaluation of this end point: During the investigation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in dominant frequency of after opioid administration<br><br>Safety variables<br>-Pulse, blodpressure, ECG changes<br>- Oxygen saturation, respiratory rate<br>- Consciousness<br>;Timepoint(s) of evaluation of this end point: During the investigation