A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking

NCT ID: NCT02266212

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.

Detailed Description

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Conditions

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Current Smokers Past Smokers Never Smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smoke

Fagerstrom test for nicotine dependence

Group Type ACTIVE_COMPARATOR

5 ml arterial blood

Intervention Type PROCEDURE

A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).

Pain

pain during post-operation Day1 to Day4

Group Type ACTIVE_COMPARATOR

5 ml arterial blood

Intervention Type PROCEDURE

A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).

Morphine

Morphine consumption during post-operation Day1 to Day4

Group Type ACTIVE_COMPARATOR

5 ml arterial blood

Intervention Type PROCEDURE

A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).

Interventions

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5 ml arterial blood

A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective general surgery are assigned to current smokers(n=100) or past smokers(n=100) or never smokers(n=100) according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.

Exclusion Criteria

* the patients undergoing major thoracic cardiovascular surgery
* the patients with significant lung lesion
* the patients with conscious disturbance
* the patients with allergic history to morphine
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Yuan-Yi Chia

anesthesia doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGHKS101-016

Identifier Type: -

Identifier Source: org_study_id

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