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Comparison of Sedation with Dexmedetomidine versus Propofol in Hysteroscopic Surgery: A Single Center Prospective Study

Comparison of Sedation with Dexmedetomidine versus Propofol in Hysteroscopic Surgery: A Single Center Prospective Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001037291
Enrollment
60
Registered
2018-06-21
Start date
2012-07-01
Completion date
2013-07-01
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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,

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.

Sponsors

Medeniyet University, Goztepe Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026