Effects of; Anesthesia, Local,Pain,in DISE Clinical Trial
Official title:
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
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | July 30, 2023 |
| Est. primary completion date | July 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 50 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Zagazig University | Zagazig | Sharkia |
| Lead Sponsor | Collaborator |
|---|---|
| Zagazig University |
Egypt,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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) | |
| Secondary | 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) | |
| Secondary | time to rescue analgesia | The time from the end of anaesthesia to ?rst use of rescue analgesia (nalbuphine) | up to 24 hours of postoperative | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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. |