Effects of; Anesthesia, Local,Pain,in DISE
Conditions
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.
Interventions
PROCEDURECombination 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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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).
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain assessment | change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation | 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 |
| hemodynamic assessment | for 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to rescue analgesia | up to 24 hours of postoperative | The time from the end of anaesthesia to first use of rescue analgesia (nalbuphine) |
| The number of patients who required nalbuphine in the postoperative period, | up to 24 hours of postoperative | to calculate the number of patients who required nalbuphine in the postoperative period, |
| extubation time | intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes) | Extubation time was calculated from time of anesthesia off till extubation and recorded in each patient |
| patient and surgeon satisfaction | assessed on the first postoperative day from both patients and surgeons. | 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 |
| intraoperative bleeding | at the end of surgery | to the nearest milliliter) was determined by the amount of blood in the suction containers and gauze sponges, based on assessment by the surgeon. |
| mean isoflurane % | intraoperative ( recorded every 5 minutes) | 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 |
Countries
Egypt
Contacts
Primary ContactHeba M EL-Asser, MD
Backup Contactamr sh Elshafei, MD
Outcome results
None listed