Deep SedationNCT05674201
Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl In Hysteroscopıc Operations.
An observational study of Deep Sedation and Ambulatory Surgery, run by Siirt Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics, recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of the ambulatory surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deep Sedation, Ambulatory Surgery, Ambulatory Surgical Procedure
- What is being tested?
- Propofol-Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2021to 15 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 patients in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study.
Who may be able to join
- AGE 18-65 ASA I AND II
Who cannot join
- OTHERS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl On Recovery And Hemodynamıcs In Hysteroscopıc Operations, That One Of The Ambulatory Anesthesıa Practices: A Randomızed Controlled Study
In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics, recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of the ambulatory surgery.
Read the detailed description
This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 participants in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study. On the day of the operation, vascular access was established with a 20 G branule in all patients before the procedure. The participants who were taken to the gynecology table were routinely monitored in the supine position as required by the procedure.
All participants were premedicated with 0.025 mg/kg Midazolam (Demizolam®, Dem, Turkey) after starting oxygen at 2 lt/min with a nasal cannula. The participants were randomly divided into two groups as Group DP and RP. Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered to both groups. Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey)
1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started. After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started.Hemodynamic data and respiratory parameters of the groups before and after sedation were recorded. The depth of anesthesia was recorded using the Ramsey sedation scale, and the recovery scores were recorded with the Modified Aldrete score. The facial pain scale was used to evaluate pain. Depth of anesthesia was provided so that the Ramsey Sedation Scale of the patients was greater than four. Patients with RSS\<4 were excluded from the study by administering additional propofol.
- Being tested
- Propofol-Dexmedetomidine
- Keywords
- Ambulatory Anesthesia, Hysteroscopy, Sedation, Dexmedetomidine, Remifentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol-DexmedetomidineCombination product
Also called Propofol-Remifentanil
Propofol-Dexmedetomidine AND Propofol-Remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Group DP | Propofol (Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey)
1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started.-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered. Receives: Combination Product: Propofol-Dexmedetomidine | |
| Group RP | Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered, After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started. Receives: Combination Product: Propofol-Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEDATİON
RAMSEY SEDATİON SKORE > 4 TİME (MİNUTE)
Measured: through study completion, an average of 1 year
RECOVERY
MODIFIED ALDRETE SCORE>9 (MİNUTE)
Measured: through study completion, an average of 1 year
DESATURATION DESATURATION
SATURATION SATURATION RATIOS (%)
Measured: DURING THE SURGERY
RESPİRATORY RATE
RESPİRATORY RATE (.../MİNUTE)
Measured: DURING THE SURGERY
END-TİDAL CO2
END-TİDAL CO2 (mmHg)
Measured: DURING THE SURGERY
INTEGRATED PULMONARY INDEX
INTEGRATED PULMONARY INDEX (1-10)
Measured: DURING THE SURGERY
Secondary outcomes (3)
HEART RATE
HEART RATE (../MİNUTE)
Measured: DURING THE SURGERY
NON INVASIVE SYSTOLİC AND BLOOD PRESSURE
NON INVASIVE BLOOD PRESSURE ( mmHg)
Measured: DURING THE SURGERY
NON INVASIVE DİASTOLİC BLOOD PRESSURE
NON INVASIVE BLOOD PRESSURE ( mmHg)
Measured: DURING THE SURGERY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start17 Jun 2021
- Primary completion1 Aug 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Siirt Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Yuzuncu Yil University
- Responsible party
- Principal investigator, ali kendal oğuz, Siirt Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674201
- Sponsor's protocol ID
- SiirtTRH
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Oguz AK, Soyalp C, Tuncdemir YE, Tekeli AE, Yuzkat N. Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jan 29;25(1):45. doi: 10.1186/s12871-025-02918-1.
PubMed 39881245
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Propofol-Dexmedetomıdıne And Propofol- Remıfentanıl On Recovery And Hemodynamıcs In Hysteroscopıc Operations, That One Of The Ambulatory Anesthesıa Practices: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT05674201
- Acronym / sponsor ID
- SiirtTRH
- Keywords
- Ambulatory Anesthesia, Hysteroscopy, Sedation, Dexmedetomidine, Remifentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Siirt Training and Research HospitalOther government
- Collaborators
- Yuzuncu Yil University
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 6 Jan 2023 (actual)
- 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.
In our study, the investigators aimed to compare the effects of dexmedetomidine-propofol and remifentanil-propofol combinations on perioperative spontaneous respiration, hemodynamics, recovery, participants, surgeon and anesthetist satisfaction in hysteroscopy, which is one of the ambulatory surgery.
Detailed description
This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 participants in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study. On the day of the operation, vascular access was established with a 20 G branule in all patients before the procedure. The participants who were taken to the gynecology table were routinely monitored in the supine position as required by the procedure.
All participants were premedicated with 0.025 mg/kg Midazolam (Demizolam®, Dem, Turkey) after starting oxygen at 2 lt/min with a nasal cannula. The participants were randomly divided into two groups as Group DP and RP. Propofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered to both groups. Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey)
1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started. After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started.Hemodynamic data and respiratory parameters of the groups before and after sedation were recorded. The depth of anesthesia was recorded using the Ramsey sedation scale, and the recovery scores were recorded with the Modified Aldrete score. The facial pain scale was used to evaluate pain. Depth of anesthesia was provided so that the Ramsey Sedation Scale of the patients was greater than four. Patients with RSS\<4 were excluded from the study by administering additional propofol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DP | – | Combination Product: Propofol-DexmedetomidinePropofol (Dexmedetomidine (Sedadomide 200 µg/2 ml, KOÇAK FARMA Turkey) 1mcg/kg bolus was administered to Group DP in 10 minutes, then 0.2-1.4 mcg/kg/hour infusion dose was started.-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered. |
| Group RP | – | Combination Product: Propofol-DexmedetomidinePropofol (Propofol-®Lipuro 1%(10 mg/ml), B. Braun Indonesia ) 1mg/kg bolus was administered, After a 0.25mcg/kg bolus of Remifentanil (Ultiva®, GlaxoSmithKline, Belgium) was administered to Group RP, a 0.025-0.1mcg/kg/minute infusion dose was started. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted prospectively after the approval of Van Yüzüncü Yıl University Ethics Committee. A total of 80 patients in 2 groups of 40 ASA I-II, aged 18-65 years were included in the study.
Key inclusion criteria (1 listed)
- AGE 18-65 ASA I AND II
Key exclusion criteria (1 listed)
- OTHERS
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 |
|---|---|---|
| Propofol-DexmedetomidineAlso: Propofol-RemifentanilPropofol-Dexmedetomidine AND Propofol-Remifentanil | Combination product | Group DP, Group RP |
Primary outcome
SEDATİON
Time frame: through study completion, an average of 1 year
RAMSEY SEDATİON SKORE > 4 TİME (MİNUTE)
RECOVERY
Time frame: through study completion, an average of 1 year
MODIFIED ALDRETE SCORE>9 (MİNUTE)
DESATURATION DESATURATION
Time frame: DURING THE SURGERY
SATURATION SATURATION RATIOS (%)
RESPİRATORY RATE
Time frame: DURING THE SURGERY
RESPİRATORY RATE (.../MİNUTE)
END-TİDAL CO2
Time frame: DURING THE SURGERY
END-TİDAL CO2 (mmHg)
INTEGRATED PULMONARY INDEX
Time frame: DURING THE SURGERY
INTEGRATED PULMONARY INDEX (1-10)
3 secondary outcomes
HEART RATE
Time frame: DURING THE SURGERY
NON INVASIVE SYSTOLİC AND BLOOD PRESSURE
Time frame: DURING THE SURGERY
NON INVASIVE DİASTOLİC BLOOD PRESSURE
Time frame: DURING THE SURGERY
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 6 Jan 2023.
- Derived from this study: PubMed 39881245Oguz AK, Soyalp C, Tuncdemir YE, Tekeli AE, Yuzkat N. Sedoanalgesia with dexmedetomidine in daily anesthesia practices: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jan 29;25(1):45. doi: 10.1186/s12871-025-02918-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Sedation and Ambulatory Surgery, run by Siirt Training and Research Hospital 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 6 Jan 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
SEDATİON (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674201, which also lists 1 linked publication.
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 6 Jan 2023.