Abdominal Hysterectomy (& Wertheim)Phase 4NCT02362022
The Effects of Morphine on Desflurane Consumption and Recovery Time
A Phase 4 study testing Morphine in people with Abdominal Hysterectomy (& Wertheim), run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures. This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Hysterectomy (& Wertheim)
- What is being tested?
- Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- undergoing total abdominal hysterectomy with general anaesthesia
Who cannot join
- renal dysfunction (cre>1.2), liver failure, cardiovascular, psychiatric, allergic and metabolic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, 01250
About this study
Official title: Comparison of Two Different Doses of Intravenous Morphine on Desflurane Consumption and Recovery Time in Patients Undergoing Total Abdominal Hysterectomy
Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures. This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic requirements and side effects during total abdominal hysterectomy.
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Being tested
- Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
| Study group | Role | What they receive |
|---|---|---|
| Group Saline | Placebo comparator | Group Saline (Group S) received i.v saline 0.9 % in 10 ml volume (n=30) Receives: Drug: Morphine |
| Group Morphine 1 | Active comparator | Group Morphine 1 (Group M1) received i.v morphine 0.1 mg kg-1, in 10 ml volume (n=30) Receives: Drug: Morphine |
| Group Morphine 2 | Active comparator | Group Morphine 2 (Group M2) received i.v morphine 0.2 mg kg-1, in 10 ml volume (n=30) Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative desflurane consumption
Measured: postoperative first hour
sedation scores for OASS scale
Measured: postoperative first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Hysterectomy (& Wertheim)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAGLA BALI,MD, Baskent University
- Investigators
- cagla bali, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362022
- Sponsor's protocol ID
- 14.09.2007/88-4
- Status last verified
- Jun 2015
- First submitted
- 4 Feb 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Doses of Intravenous Morphine on Desflurane Consumption and Recovery Time in Patients Undergoing Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT02362022
- Acronym / sponsor ID
- 14.09.2007/88-4
- Conditions
- Abdominal Hysterectomy (& Wertheim)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Combination of volatile and opioid agents are used to achieve unconsciousness, haemodynamic stability and analgesia for surgical prosedures. This prospective, randomized, double-blind, controlled study evaluates the effects of two different doses of morphine sulphate (0.1 mg/kg and 0.2 mg/kg), on desflurane consumption, recovery characteristics, postoperative analgesic requirements and side effects during total abdominal hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Saline | Placebo comparator | Drug: MorphineGroup Saline (Group S) received i.v saline 0.9 % in 10 ml volume (n=30) |
| Group Morphine 1 | Active comparator | Drug: MorphineGroup Morphine 1 (Group M1) received i.v morphine 0.1 mg kg-1, in 10 ml volume (n=30) |
| Group Morphine 2 | Active comparator | Drug: MorphineGroup Morphine 2 (Group M2) received i.v morphine 0.2 mg kg-1, in 10 ml volume (n=30) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- undergoing total abdominal hysterectomy with general anaesthesia
Key exclusion criteria (1 listed)
- renal dysfunction (cre>1.2), liver failure, cardiovascular, psychiatric, allergic and metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineGroup Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30) | Drug | Group Morphine 1, Group Morphine 2, Group Saline |
Primary outcome
postoperative desflurane consumption
Time frame: postoperative first hour
sedation scores for OASS scale
Time frame: postoperative first hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cagla bali principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine in people with Abdominal Hysterectomy (& Wertheim), run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative desflurane consumption (time frame: postoperative first hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.