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Clinical Trials/NCT04300595
NCT04300595
Recruiting
N/A

The Efficacy of Combined Local and General Anesthesia or General Anesthesia Alone in External Dacryocystorhinostomy: A Randomized Controlled Study

Zagazig University1 site in 1 country24 target enrollmentApril 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Effects of; Anesthesia, Local,Pain,in DISE
Sponsor
Zagazig University
Enrollment
24
Locations
1
Primary Endpoint
hemodynamic assessment
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure

Detailed Description

* calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions * calculate total anesthetic time * assess intraoperative changes in hemodynamics * assess intraoperative blood loss * evaluate surgeon and patient satisfaction * recognize whether this was related with changes in postoperative analgesia . * Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
July 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Mohamed EL -Asser,MD

Heba Mohamed EL -Asser,MD

Zagazig University

Eligibility Criteria

Inclusion Criteria

  • Age from 20 to 50 years old.
  • American society of anesthesiologists (ASA) physical status I or II.
  • Elective unilateral Dacryocystorhinostomy with paranasal skin incision.

Exclusion Criteria

  • Endoscopic Dacryocystorhinostomy.
  • Allergy to amide local anesthetics or opioids.
  • Drug abuse.
  • Pregnancy.

Outcomes

Primary Outcomes

hemodynamic assessment

Time Frame: for 24 hours

Change in arterial blood pressure were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours

postoperative pain assessment

Time Frame: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation

To quantify the intensity of postoperative pain, the patients were asked to use a 10-cm visual analog scale (VAS) grade from 0-cm (no pain) to 10-cm (the worst possible pain) 1, 2, 4, 6, 8, 12, and 24 h after extubation

Secondary Outcomes

  • time to rescue analgesia(up to 24 hours of postoperative)
  • extubation time(intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes))
  • patient and surgeon satisfaction(assessed on the first postoperative day from both patients and surgeons.)
  • The number of patients who required nalbuphine in the postoperative period,(up to 24 hours of postoperative)
  • mean isoflurane %(intraoperative ( recorded every 5 minutes))
  • intraoperative bleeding(at the end of surgery)

Study Sites (1)

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