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Completed

NCT Number: NCT05397301

Controlled Sedoanalgesia in External DCR Surgery

In our study, we aim to compare general anesthesia and controlled sedoanalgesia methods in dacryocystorhinostomy (DCR) surgery in terms of hemodynamic data, bleeding amount, postoperative complications (bleeding, pain, etc.) and anesthesia satisfaction in a prospective and randomized controlled manner.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludağ Üniversitesi Tip Fakültesi

Bursa, Ni̇lüfer, 16000, Turkey (Türkiye)

About this study

The patients were routinely monitored in the operating room in accordance with the standard protocol for elective surgeries, and the preoperative findings (blood pressure, oxygen saturation, cardiac rhythm, peak heart rate) were recorded.

The decision of routine anesthesia was not interfered with. The data of the patients were collected as GA group if general anesthesia was applied and SA group if sedoanalgesia was applied. If general anesthesia was preferred, anesthesia induction was performed with propofol, fentanyl and rocuronium, and sevoflurane was used for anesthesia maintenance. Intravenous midazolam and dexmedetomidine infusions were administered to patients for whom sedoanalgesia was preferred. The sedation level of these patients was followed up with the Ramsay sedation scale (RSS) and capnography monitoring was performed.

Whether general anesthesia or sedoanalgesia was preferred, local anesthesia was administered to all patients by the surgical team and intraoperative hemodynamic data (mean arterial pressure, heart rate, oxygen saturation) were followed.

In addition to patients recruited for the study, hemodynamic data after induction, endotracheal intubation, surgical incision, and extubation were also recorded.

Depth of anesthesia was monitored with a bispectral index monitor for both groups.

Intraoperative bleeding amount, canal damage, etc. Intraoperative complications such as In this study, the pain levels of the patients were evaluated by visual pain score (VAS) at 0 and 30 minutes, 1st, 4th, 8th and 12th hours. Analgesic requirement, postoperative nausea-vomiting and time, duration of surgery, length of hospital stay, surgery-related complications (ecchymosis, epistaxis, hematoma, edema, etc.) were recorded. Patient and surgical team satisfaction of the patients was evaluated using a 5-point Likert Scale.

The necessary measurements of the eyes and adnexa (visual acuity, meibomian gland measurement, tear breakout time, schirmer) for which detailed eye examinations of the patients will be performed preoperatively and postoperatively on the 1st day, 1st week, 1st month, 3rd month and 6th month. tests, intraocular pressure, pupil width, lens density, corneal topography, anterior and posterior segment Optical coherence tomography, etc.) tear duct examination and lavage were performed. The patient's complaints about eye diseases were recorded. As a result of the study, in addition to local anesthesia in DCR surgery, sedoanalgesia and general anesthesia methods were compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary DCR surgery to be performed
  • 18 years and older patients
  • Having an American Society of Anesthesiology score of 1, 2, 3
  • Having approved and signed the informed consent form

Exclusion criteria

  • Patients younger than 18 years old
  • Patients with an American Society of Anesthesiology score of 4 and above
  • Patients who do not accept informed consent
  • History of drug allergy and opioid tolerance
  • Uncontrolled diabetes mellitus
  • Coagulation disorder
  • Cases with severe liver and kidney disease
  • Those who refused to participate in the study
  • They will have DCR surgery again

Treatment and study plan

Controlled sedoanalgesia

Procedure

Controlled sedoanalgesia was applied with Bispectral index and dexmedetomidine

Primary outcomes

  1. hemodynamic data

    Time frame: through surgery completion

    blood pressure (mm/hg)

  2. hemodynamic data

    Time frame: through surgery completion

    heart rate (bpm)

  3. hemodynamic data

    Time frame: through surgery completion

    peripheral oxygen saturation (percent)

  4. amount of bleeding

    Time frame: amount of bleeding calculated during surgery

    the amount that bleeds into the aspirator and cottons during the surgery (ml)

Secondary outcomes

  1. postoperative complications

    Time frame: postoperatif 12 hour

    pain

  2. postoperative complications

    Time frame: postoperatif 12 hour

    nause and vomiting

Sponsors and collaborators

Lead sponsor

Turkish Society of Anesthesiology and Reanimation

Other

Registry information

Official study title

Comparison of Controlled Sedoanalgesia and General Anesthesia in Dacryocystorhinostomy Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 31, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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