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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general anesthesia (Group G) | Active Comparator | Patients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G) |
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| Local anesthesia (Group L) | Active Comparator | Patients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery | 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. |
| 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 |
| 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 % |
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Inclusion Criteria:• Age from 20 to 50 years old.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba M EL-Asser, MD | Contact | 00201062393152 | aseeaswad1@yahoo.com | |
| amr sh Elshafei, MD | Contact | 00201225800795 | amrshaaban85@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Heba M EL-Asser, MD | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Recruiting | Zagazig | Sharqia Province | 002055 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30228368 | Background | 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. | |
| 20039868 | Background | 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. |
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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).
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In the Group G, Local infiltration of 10 ml normal saline at site of skin incision after marking and analgesia was provided by 40 µg/kg nalbuphine loaded in 10 ml syringe IV before skin incision and subsequent injections of 10-20 µg/kg nalbuphine as necessary. The last supplemental bolus of nalbuphine was given at least 30 min before the end of the operation In the Group L, Local infiltration of 10 ml mixture of 20 mg/ml lidocaine and 10 µg/ml epinephrine (instead of saline used in Group G) and normal saline in 10 ml syringe was given IV (instead of nalbuphine used in Group G).
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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 .
| assessed on the first postoperative day from both patients and surgeons. |
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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