OPIOID FREE VERSUS OPIOID BALANCED ANAESTHESIA IN MIDDLE EAR SURGERY AIM OF THE WORK
Primary aim:
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Secondary aim:
Monitoring analgesia, post-operative satisfaction and drowsiness.
Condition or disease | Intervention/treatment | Phase |
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PONV Opioid Use | Drug: Fentanyl Opioid anesthesia Drug: Saline Nonopioid anesthesia | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Masking Description: | Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia. |
Primary Purpose: | Treatment |
Official Title: | Opioid Free Versus Opioid Balanced Anesthesia in Middle Ear Surgery. |
Actual Study Start Date : | January 16, 2019 |
Actual Primary Completion Date : | May 21, 2019 |
Actual Study Completion Date : | May 22, 2019 |
Arm | Intervention/treatment |
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Active Comparator: Fentanyl Opioid Anesthesia
Fentanyl (1mg/kg i.v.) will be administered before general anaesthesia (GA). GA will be maintained with inhalation anaesthetics (isoflurane) at a minimum alveolar concentration of 0.7-1.3.
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Drug: Fentanyl Opioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
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Placebo Comparator: Saline Nonopioid Anesthesia
Opioid free anesthesia (syringe of saline is given instead of fentanyl) and the same general anesthesia is given as group A(muscle relaxant ,propofol, inhalation for maintance).
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Drug: Saline Nonopioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Egypt | |
Alexandria Faculty of Medicine | |
Alexandria, Egypt, 21111 |
Tracking Information | |||||
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First Submitted Date ICMJE | January 15, 2019 | ||||
First Posted Date ICMJE | January 18, 2019 | ||||
Last Update Posted Date | July 10, 2019 | ||||
Actual Study Start Date ICMJE | January 16, 2019 | ||||
Actual Primary Completion Date | May 21, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PONV [ Time Frame: 72 hours ] Post operative nausea and vomiting from 0-3 for nausea and 0 to 4 for vomiting
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Opioid Free Versus Opioid Balanced Anesthesia | ||||
Official Title ICMJE | Opioid Free Versus Opioid Balanced Anesthesia in Middle Ear Surgery. | ||||
Brief Summary |
OPIOID FREE VERSUS OPIOID BALANCED ANAESTHESIA IN MIDDLE EAR SURGERY AIM OF THE WORK Primary aim: To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery Secondary aim: Monitoring analgesia, post-operative satisfaction and drowsiness. |
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Detailed Description |
After approval of the Ethical Committee of Faculty of Medicine, Alexandria University and having an informed written consent from every patient included in the study, the present study will be carried out in Alexandria Main University Hospitals on sixty adult patients belonging to ASA class I or II scheduled for middle ear surgery under general anaesthesia. (The sample size is approved to be sufficient by the Department of Statistics, Medical Research Institute, University of Alexandria). Inclusion criteria:
I will compare postoperative nausea and vomiting (PONV) in patients scheduled for middle ear surgery. Sixty patients will be randomly allocated to receive either balanced anaesthesia (group A) using fentanyl, propofol and isoflurane, or opioid free anaesthesia (group B) using propofol and isoflurane. Pain scores, nausea ⁄ vomiting scores, conditions for surgery and analgesic requirements will be recorded post operatively. Anaesthetic management Preoperative management All patients will be visited before surgery to be clinically assessed and the preoperative surveillance includes:
On arrival to the operating room and before anaesthetic induction all patients will be monitored by the standard routine monitoring, which include:
Premedication with Midazolam in a dose of 0.02mg/ Kg will be used. Induction Preoxygenation with 100 % O2 for 3 minutes. General anaesthesia will be induced by propofol (2 mg/kg) and atracurium (0.5 mg/kg) intravenously guided by a nerve stimulator, followed by endotracheal intubation after loss of train of four. All the patients will receive i.v. acetaminophen (1000 mg) _20 min after induction and i.v. ketorolac (30 mg). Local analgesia will be injected by surgeon. All patients will receive beta blocker (Inderal 1mg) and magnesium sulphate (15-30mg/kg) for achieving hypotensive anaesthesia. Maintenance Maintenance of general anaesthesia with a mixture of isoflurane (1MAC) and oxygen. All patients will be mechanically ventilated with an anaesthesia machine to keep SpO2 > 95% and end-tidal CO2 between 35-45 mmHg. Additional atracurium will be administrated as appropriate in bolus doses if needed. Group A Fentanyl (1mg/kg i.v.) will be administered before general anaesthesia (GA). GA will be maintained with inhalation anaesthetics (isoflurane) at a minimum alveolar concentration of 0.7-1.3. Group B Opioid free anesthesia (syringe of saline is given instead of fentanyl) and the same general anesthesia is given as group A(muscle relaxant ,propofol, inhalation for maintance). Recovery At the end of surgery, isoflurane will be discontinued, 100% oxygen will be given, all patients will be planned for extubation in the operating room depending on recovery criteria after complete reversal of muscle relaxant with neostigmine (up to 5 mg). Tracheal extubation will be performed in a semi- sitting position after fulfilling the criteria for extubation. Extubation criteria include: a fully conscious patient, haemodynamic stability, reversal of neuromuscular blockade, TOF ratio 0.9 - 1 on nerve stimulator, and the ability of head lift for 5 seconds. Postoperative multimodal pain management Postoperative pain will be treated with i.v. acetaminophen (1000mg) and i.v. ketorolac (30 mg) every 6 h for the first 24 h. Postoperative pain will be measured on an 11-point numeric pointscale (NPS). management of PONV Dexamethasone (8 mg i.v.) will be administered during induction, ondansetron (4 mg i.v.) and metoclopramide (10 mg i.v.) post operative if Patients complaining of PONV after discharge from the PACU. Measurements
Sedation score: 0. Alert
6. Satsifacation of patient assessment by QoR40 questionnaire The QoR-40 is a global measure of quality of recovery. It incorporates five dimensions: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).(29) Timing Hemodynamic (blood pressure, pulse) of Patients will be assessed during the surgery every 10 minutes and at 1 and 2 h after the end of surgery and at discharge from the day unit. At each of these times, the nurse recorded the incidence and worst severity of pain, nausea and emesis since the last evaluation using the same criteria as before. Any medication will be given for pain or nausea (administered for moderate-severe symptoms, or at patient request) will be also recorded, till the time of discharge. Patients will be discharged with medication comprising slow-release ibuprofen. The following day, the researcher will telephone the patient to assess the incidence and worst severity of pain, nausea and emesis since discharge and whether any analgesia or antiemetics will be taken. Patients will be also asked to record their satisfaction with the control of pain, the control of sickness and their overall day surgery experience on 11-point (0-10) verbal rating scales. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia. Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | May 22, 2019 | ||||
Actual Primary Completion Date | May 21, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03809949 | ||||
Other Study ID Numbers ICMJE | 050108073(18/12/2018) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Mohammad Hazem I. Ahmad Sabry, University of Alexandria | ||||
Study Sponsor ICMJE | University of Alexandria | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Alexandria | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |