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

NCT ID: NCT04300595

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-07-30

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.

Conditions

Effects of; Anesthesia, Local,Pain,in DISE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

general anesthesia (Group G)

Patients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G)

Group Type: ACTIVE_COMPARATOR

Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery

Intervention Type: PROCEDURE

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.

Local anesthesia (Group L)

Patients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).

Group Type: ACTIVE_COMPARATOR

Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Heba Mohamed EL -Asser,MD

Heba Mohamed EL -Asser,MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba M EL-Asser, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University

Zagazig, Sharqia Province, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Heba M EL-Asser, MD

Role: CONTACT

aseeaswad1@yahoo.com

00201062393152

amr sh Elshafei, MD

Role: CONTACT

amrshaaban85@gmail.com

00201225800795

Facility Contacts

Zagazig University

Role: primary

info_medicine@zu.edu.eg

0552363635

References

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.

Reference Type: BACKGROUND

PMID: 30228368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20039868 (View on PubMed)

Other Identifiers

local anesthesia in DCR

Identifier Type: -

Identifier Source: org_study_id