Anesthetic Approaches for Dacryocystorhinostomy Surgery: The Effect of Adding Local Anesthesia to General Inhalational Anesthesia

Not Applicable

Recruiting

• Conditions: Effects of; Anesthesia, Local,Pain,in DISE
• Interventions: Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery

• Registration Number: NCT04300595
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Study Start: 2020-04-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia (Group G)	Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery	Patients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G)
Local anesthesia (Group L)	Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery	Patients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).

Primary Outcome Measures

Name	Time	Method
hemodynamic assessment	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	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 Outcome Measures

Name	Time	Method
time to rescue analgesia	up to 24 hours of postoperative	The time from the end of anaesthesia to first use of rescue analgesia (nalbuphine)
extubation time	intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes)	Extubation time was calculated from time of anesthesia off till extubation and recorded in each patient
patient and surgeon satisfaction	assessed on the first postoperative day from both patients and surgeons.	An overall satisfaction score according to postoperative analgesia .; * nil = 0; * mild = 1; * good = 2; * excellent = 3 was recorded on the first postoperative day from both patients and surgeons. The acceptance of combination of LA and GA was questioned and the patients who applied for a successive operation on the other eye were recorded
The number of patients who required nalbuphine in the postoperative period,	up to 24 hours of postoperative	to calculate the number of patients who required nalbuphine in the postoperative period,
mean isoflurane %	intraoperative ( recorded every 5 minutes)	Isoflurane concentration was adjusted according to hemodynamics by increase or decrease concentration when heart rate or mean arterial blood pressure increase or decrease more than 20-30% of the basal preoperative record, respectively and after nalbuphine dose failed to adjust hemodynamics
intraoperative bleeding	at the end of surgery	to the nearest milliliter) was determined by the amount of blood in the suction containers and gauze sponges, based on assessment by the surgeon.

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt