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

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

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

Study Overview

• Status: Recruiting
• Conditions: Effects of; Anesthesia, Local,Pain,in DISE
• Intervention / Treatment: Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba M EL-Asser, MD; Phone Number: 00201062393152; Email: aseeaswad1@yahoo.com
• Study Contact Backup: Name: amr sh Elshafei, MD; Phone Number: 00201225800795; Email: amrshaaban85@gmail.com

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 002055
      • Recruiting
      • Zagazig University
      • Contact: Zagazig University; Phone Number: 0552363635; Email: info_medicine@zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: general anesthesia (Group G); Patients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G)	Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery; all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). In both groups, general anesthesia was induced with 2 mg/kg propofol and tracheal intubation was facilitated by 0.1 mg/kg cisatracurium. All patients underwent mechanical ventilation with 100% oxygen. Anesthesia was maintained with isoflurane, and muscle relaxation was provided by an injection of cisatracurium 0.02 mg/kg every 20 minutes.
Active Comparator: Local anesthesia (Group L); Patients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).	Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery; all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). In both groups, general anesthesia was induced with 2 mg/kg propofol and tracheal intubation was facilitated by 0.1 mg/kg cisatracurium. All patients underwent mechanical ventilation with 100% oxygen. Anesthesia was maintained with isoflurane, and muscle relaxation was provided by an injection of cisatracurium 0.02 mg/kg every 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain assessment	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	change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation
hemodynamic assessment	Change in heart rate 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	for 24 hours
hemodynamic assessment	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	for 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation time	Extubation time was calculated from time of anesthesia off till extubation and recorded in each patient	intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes)
mean isoflurane %	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 ( recorded every 5 minutes)
time to rescue analgesia	The time from the end of anaesthesia to first use of rescue analgesia (nalbuphine)	up to 24 hours of postoperative
The number of patients who required nalbuphine in the postoperative period,	to calculate the number of patients who required nalbuphine in the postoperative period,	up to 24 hours of postoperative
intraoperative bleeding	to the nearest milliliter) was determined by the amount of blood in the suction containers and gauze sponges, based on assessment by the surgeon.	at the end of surgery
patient and surgeon satisfaction	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	assessed on the first postoperative day from both patients and surgeons.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Heba M EL-Asser, MD, Zagazig University

Publications and helpful links

General Publications

• Scawn RL, Allen MJ, Rose GE, Verity DH. Randomised, masked study of local anaesthesia administered prior to external dacryocystorhinostomy under general anaesthesia. Eye (Lond). 2019 Mar;33(3):374-379. doi: 10.1038/s41433-018-0201-5. Epub 2018 Sep 18.
• Ghali AM, El Btarny AM. The effect on outcome of peribulbar anaesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia. 2010 Mar;65(3):249-53. doi: 10.1111/j.1365-2044.2009.06191.x. Epub 2009 Dec 23.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Estimated): July 30, 2023
• Study Completion (Estimated): July 30, 2023

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: local anesthesia in DCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No