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Trial registered on ANZCTR


Registration number
ACTRN12618001037291
Ethics application status
Approved
Date submitted
10/06/2018
Date registered
21/06/2018
Date last updated
21/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Sedation with Dexmedetomidine versus Propofol in Hysteroscopic Surgery: A Single Center Prospective Study
Scientific title
Comparison of Sedation with Dexmedetomidine versus Propofol in Hysteroscopic Surgery: A Single Center Prospective Study
Secondary ID [1] 295155 0
None
Universal Trial Number (UTN)
U1111-1215-5008
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysteroscopic surgery 308264 0
Condition category
Condition code
Anaesthesiology 307279 307279 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty patients undergoing minor hysteroscopic surgery were randomized to receive either dexmedetomidine (n= 30) or propofol (n= 30) treatments. Dexmedetomidine was infused at 1 µg/kg for 10 minutes followed by a 0.7 µg/kg/h maintenance infusion. Propofol was infused as a bolus of 1.5 mg/kg followed by a 2.5 mg/kg/h maintenance infusion. Fentanyl 1.5 mcg/kg and dormicum 0.03 mg/kg were administered to all patients as premedication therapy before the hysteroscopic surgery. Patients were monitored, and mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SpO2) were recorded. In addition, riker sedation-agitation scale (SAS), and visual analogue scale ( VAS) were recorded for all patients.Dexmedetomidin group and propofol group were compared in terms of these variables. Anaesthetist will be administering the intervention.
Intervention code [1] 301494 0
Treatment: Drugs
Comparator / control treatment
The comparator is propofol.
Control group
Active

Outcomes
Primary outcome [1] 306233 0
Mean arterial pressure (MAP).
Patients were monitored and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with automatic sphygmomanometer. Patient monitoring was started at pre-operative period and was contined until 60 min after operation. MAP was automatically calculated from SBP and DBP vales by patient monitoring.
Its formula was as follows: [(2 x DBP) + SBP] / 3.
Timepoint [1] 306233 0
The following evaluation time points were defined for the MAP:
Pre-operative (basal), T1: first minute (min.) of the initiation of sedative infusion, T2: 5 min. after the initiation of sedative infusion, T3: 10 min. after the initiation of sedative infusion, T4: the end of operation, T5: 1 min. after operation, T6: 15 min. after operation, T7: 30 min. after operation.
Primary outcome [2] 306319 0
Heart rate (HR).
Patients were monitored and heart rate was obtained from this monitoring. Patient monitoring was started at pre-operative period and was contined until 60 min after operation. Heart rate was defined as number of beats per minute.
Timepoint [2] 306319 0
The following evaluation time points were defined for the HR:
Pre-operative (basal), T1: first minute (min.) of the initiation of sedative infusion, T2: 5 min. after the initiation of sedative infusion, T3: 10 min. after the initiation of sedative infusion, T4: the end of operation, T5: 1 min. after operation, T6: 15 min. after operation, T7: 30 min. after operation.
Primary outcome [3] 306320 0
Oxygen saturation (SpO2).
Patients were monitored and SpO2 was obtained from pulse oximetry.
Timepoint [3] 306320 0
The following evaluation time points were defined for the SpO2:
Pre-operative (basal), T1: first minute (min.) of the initiation of sedative infusion, T2: 5 min. after the initiation of sedative infusion, T3: 10 min. after the initiation of sedative infusion, T4: the end of operation, T5: 1 min. after operation, T6: 15 min. after operation, T7: 30 min. after operation.
Secondary outcome [1] 347932 0
Riker sedation-agitation scale (SAS) (it is also primary outcome).
It was assesed as follows:
7 (Dangerous agitation) Pulling at endotracheal tube, trying to remove catheters, climbing over bed rail, striking at staff, thrashing side to side
6 (Very agitated) Does not calm, despite frequent verbal reminding of limits; requires physical restraints, biting endotracheal tube
5 (Agitated) Anxious or mildly agitated, attempting to sit up, calms down to verbal instructions
4 (Calm and cooperative) Calm, awakens easily, follows commands
3 (Sedated) Diffi cult to arouse; awakens to verbal stimuli or gentle shaking, but drifts off again; follows simple commands
2 (Very sedated) Arouses to physical stimuli, but does not communicate or follow commands, may move spontaneously
1 (Unable to rouse) Minimal or no response to noxious stimuli, does not communicate or follow commands.
Timepoint [1] 347932 0
The following evaluation time points were defined for the Riker Sedation-Agitation Scale:
-1st minute of post operative period
-15th minutes of post operative period
-30th minutes of post operative period
Secondary outcome [2] 348165 0
Visual analogue scale (VAS) (it is also primary outcome).
Post-operative pain score was assessed with a 10-point visual analogue scale (VAS, 1 point = no pain, and 10 point = worst pain imaginable).
Timepoint [2] 348165 0
The following evaluation time points were defined for the Visual analogue scale (VAS):
-1st minute of post operative period
-15th minutes of post operative period
-30th minutes of post operative period
Secondary outcome [3] 348166 0
Time to discharge from the postanesthesia care unit (PACU) (Secondary outcome)
Timepoint [3] 348166 0
Following the end of the operation, patients were taken to the Post Anesthesia Care Unit (PACU). The modified Aldrete's scoring system was used for determining when patients were leaved from the PACU. Patients were discharged from PACU when their modified Aldrete's scoring system reached greater than or equal to 9. The time until modified Aldrete's scoring system reached greater than or equal to 9 were recorded for all patients in the PACU.

Eligibility
Key inclusion criteria
A total of 60 patients scheduled minor hysteroscopic surgery and aged between 18-65 years, with American Society of Anaesthesiologist (ASA) grades I or II, were enrolled in this randomized and prospective study.
Minimum age
18 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(I) ASA grades III or higher; (II) previous history of hepatic, renal or cardiovascular diseases; (III) known allergy to any of the used medications; (IV) those with body mass index > 30; (V) blood pressure > 160/110 mmHg, or < 100/50 mmHg; (VI) heart rate >120.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized by a computer-generated scheme (computerised sequence generation) to receive dexmedetomidine or propofol.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis was conducted with SPSS for Windows version 22.0 (SPSS Inc., Chicago, IL, USA). Continuous data were presented as mean ± standard deviation, and categorical data were presented as percentage. Normality assessment of continuous data were performed with Kolmogorov-Smirnov and/or Shapiro-Wilk tests. Continuous data were compared with Student’s t test for parametric data and Mann Whiyney U test for non-parametric data. Analysis of variance was performed for the comparison of repeated measurements of hemodynamic variables. Post hoc comparisons among the repeated measures in each group were performed by the Tukey HSD and/or LSD method, if appropriate. A value of P < 0.05 was considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10541 0
Turkey
State/province [1] 10541 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 299744 0
Hospital
Name [1] 299744 0
Medeniyet University, Goztepe Training and Research Hospital
Address [1] 299744 0
Ressam Salih Ermez street. No:14 Kadikoy/Istanbul
Country [1] 299744 0
Turkey
Primary sponsor type
Hospital
Name
Medeniyet University, Goztepe Training and Research Hospital
Address
Ressam Salih Ermez street. No:14 Kadikoy/Istanbul
Country
Turkey
Secondary sponsor category [1] 299082 0
None
Name [1] 299082 0
Address [1] 299082 0
Country [1] 299082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300635 0
Medeniyet University, Goztepe Training and Research Hospital Ethic Committee
Ethics committee address [1] 300635 0
Ressam Salih Ermez street. No:14 Kadikoy/Istanbul
Ethics committee country [1] 300635 0
Turkey
Date submitted for ethics approval [1] 300635 0
21/06/2012
Approval date [1] 300635 0
28/06/2012
Ethics approval number [1] 300635 0
23/B

Summary
Brief summary
Hysteroscopy is simple, safe and one of the most common performed outpatient procedures for the both diagnosis and treatment of uterine diseases. Although this procedure has a lot of advantages, the most important disadvantage is severe pain due to uterine distention and cervical dilatation.. Because of increased pain and anxiety related to hysteroscopy, an effective sedation and analgesia must be provided during the procedure to achieve maximum patient comfort and cooperation.
A rapid shift from general anesthesia to intravenous sedation has been seen in hysteroscopic surgeries. Combination of a sedative agent with an opioid analgesic is a commonly performed method to provide an effective anesthesia. The most commonly used sedative drug for conscious sedation is propofol due to its fast effect, easy titration and short half life. It can decrease the patient anxiety and pain, and increase patient comfort. However, propofol may cause some serious problems such as respiratory depression, hypotension and hemodynamic instability. Therefore, to determine an ideal sedative drug during hysteroscopy surgery is essential.
Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. It has analgesic properties, and provides conscious sedation and sufficient analgesia without respiratory depression. It also reduces stress response to the surgery, and associated with better hemodynamic stability. Therefore, dexmedetomidine has become a commonly used sedative agent especially in intensive care unit. Besides, it may be an important agent for outpatient procedures, such as hysteroscopy.
In previous studies, it has been demonstrated that dexmedetomidine is a more beneficial sedative agent than propofol for conscious sedation during different ambulatory surgeries. However, there is no study comparing the effects of dexmedetomidine versus propofol in patients undergoing minor hysteroscopy surgeries.
The aim of this study is to compare the sedative, analgesic and hemodynamic effects of dexmedetomidine versus propofol in patients undergoing minor hysteroscopy surgery.
Trial website
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 84286 0
Dr Tugba Bingol Tanriverdi
Address 84286 0
Department of Anesthesiology, Mehmet Akif Inan Training and Research Hospital, Ertugrul Street, 63300, Sanliurfa, Turkey.
Country 84286 0
Turkey
Phone 84286 0
+90 5418842232
Fax 84286 0
Email 84286 0
tuggbabingol@gmail.com
Contact person for public queries
Name 84287 0
Dr Tugba Bingol Tanriverdi
Address 84287 0
Department of Anesthesiology, Mehmet Akif Inan Training and Research Hospital, Ertugrul Street, 63300, Sanliurfa, Turkey.
Country 84287 0
Turkey
Phone 84287 0
+90 5418842232
Fax 84287 0
Email 84287 0
tuggbabingol@gmail.com
Contact person for scientific queries
Name 84288 0
Dr Tugba Bingol Tanriverdi
Address 84288 0
Department of Anesthesiology, Mehmet Akif Inan Training and Research Hospital, Ertugrul Street, 63300, Sanliurfa, Turkey.
Country 84288 0
Turkey
Phone 84288 0
+90 5418842232
Fax 84288 0
Email 84288 0
tuggbabingol@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary