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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Effects of; Anesthesia, Local,Pain,in DISE

Intervention / Treatment
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* Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The day before surgery and after obtaining written informed consent and full history taking, 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).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: general anesthesia (Group G)<br>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<br>* 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.<br>|
| Active Comparator: Local anesthesia (Group L)<br>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<br>* 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.<br>|

What is the study measuring?
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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. |