Study Results
Results pending
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Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-16
Study Completion Date
2019-05-22
Brief Summary
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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.
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
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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:
* Patients of either sex.
* American Society Anesthesiologists' physical status I-II.
* Age between 18 and 50 years. Exclusion criteria:(depend on table 1)
* Patients with gastrointestinal disease.
* A history of motion sickness, or a previous episode of PONV.
* Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
* Those who were pregnant or menstruating.
* History of opioid or drug abuse. METHODS Patients will be randomly allocated into two equal groups (thirty patients each) using the closed envelope method.
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:
* Haematological screening (Complete blood picture, Serum electrolytes).
* Standard coagulation studies e.g. prothrombin time, international normalized ratio (PT-INR).
On arrival to the operating room and before anaesthetic induction all patients will be monitored by the standard routine monitoring, which include:
* A 5-lead electrocardiography.
* A non-invasive blood pressure (NIBP) (mmHg).
* Pulse oximetry (%).
* Capnography. (End Tidal CO2 pattern and value in mmHg).
* Temperature monitoring. A peripheral intravenous cannula of 20 gauges will be inserted in a dorsal vein of the non-dominant hand.
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
1. Demographic data:
Age (years), sex, weight (kilograms).
2. Hemodynamic parameters:
* Pulse oximetry (%)
* Heart rate (HR). Beats/minute
* Mean Non-Invasive arterial blood pressure (NIBP) (mmHg)
3. Pain assessment The level of pain will be assessed on an 11-point NPS. Patients will be asked to determine their own 'acceptable' pain score.
The 11-point numeric scale ranges from '0' representing no pain extreme to '10' representing the other pain extreme (worst pain imaginable).(8)
4. Nausea and vomiting assessment (table2,3) Patients will be asked to rate the worst episode of PONV on a four-point verbal rating scale (VRS) (none, mild, moderate, or severe). Patients were also will be asked whether they experienced retching or vomiting.
5. Sedation assessment
Sedation score:
0\. Alert
1. Mild, drowsy, easy to awake
2. Moderate, easy to arouse
3. Severe: somnolent difficult to arouse
4. Sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours.
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.
(The sample size is approved to be sufficient by the Department of Statistics, Medical Research Institute, University of Alexandria).
Inclusion criteria:
* Patients of either sex.
* American Society Anesthesiologists' physical status I-II.
* Age between 18 and 50 years. Exclusion criteria:(depend on table 1)
* Patients with gastrointestinal disease.
* A history of motion sickness, or a previous episode of PONV.
* Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
* Those who were pregnant or menstruating.
* History of opioid or drug abuse. METHODS Patients will be randomly allocated into two equal groups (thirty patients each) using the closed envelope method.
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:
* Haematological screening (Complete blood picture, Serum electrolytes).
* Standard coagulation studies e.g. prothrombin time, international normalized ratio (PT-INR).
On arrival to the operating room and before anaesthetic induction all patients will be monitored by the standard routine monitoring, which include:
* A 5-lead electrocardiography.
* A non-invasive blood pressure (NIBP) (mmHg).
* Pulse oximetry (%).
* Capnography. (End Tidal CO2 pattern and value in mmHg).
* Temperature monitoring. A peripheral intravenous cannula of 20 gauges will be inserted in a dorsal vein of the non-dominant hand.
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
1. Demographic data:
Age (years), sex, weight (kilograms).
2. Hemodynamic parameters:
* Pulse oximetry (%)
* Heart rate (HR). Beats/minute
* Mean Non-Invasive arterial blood pressure (NIBP) (mmHg)
3. Pain assessment The level of pain will be assessed on an 11-point NPS. Patients will be asked to determine their own 'acceptable' pain score.
The 11-point numeric scale ranges from '0' representing no pain extreme to '10' representing the other pain extreme (worst pain imaginable).(8)
4. Nausea and vomiting assessment (table2,3) Patients will be asked to rate the worst episode of PONV on a four-point verbal rating scale (VRS) (none, mild, moderate, or severe). Patients were also will be asked whether they experienced retching or vomiting.
5. Sedation assessment
Sedation score:
0\. Alert
1. Mild, drowsy, easy to awake
2. Moderate, easy to arouse
3. Severe: somnolent difficult to arouse
4. Sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours.
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.
Conditions
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PONV
Opioid Use
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Outcome Assessors
Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia.
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Fentanyl Opioid anesthesia
Intervention Type
DRUG
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
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).
Group Type
PLACEBO_COMPARATOR
Saline Nonopioid anesthesia
Intervention Type
DRUG
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Interventions
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Fentanyl Opioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Intervention Type
DRUG
Saline Nonopioid anesthesia
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients of either sex.
* American Society Anesthesiologists' physical status I-II.
* Age between 18 and 50 years.
* American Society Anesthesiologists' physical status I-II.
* Age between 18 and 50 years.
Exclusion Criteria
* Patients with gastrointestinal disease.
* A history of motion sickness, or a previous episode of PONV.
* Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
* Those who were pregnant or menstruating.
* History of opioid or drug abuse.
* A history of motion sickness, or a previous episode of PONV.
* Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
* Those who were pregnant or menstruating.
* History of opioid or drug abuse.
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Alexandria
OTHER
Sponsor Role
lead
Responsible Party
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Mohammad Hazem I. Ahmad Sabry
Lecturer of Anesthesia
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Alexandria Faculty of Medicine
Alexandria, , Egypt
Site Status
Countries
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Egypt
References
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Moore KL, Dalley AF. Clinically orientated anatomy. 4th ed. Philadelphia: Lippinocott Williams & Wilkins; 1999.
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Morgan EG, Mikhail MS, Murray MJ. Clinical anesthesiology. 4th ed. New York: Lange Medical Books/McGraw-Hill; 2006.
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Fujii Y, Toyooka H, Tanaka H. Prophylactic antiemetic therapy with a combination of granisetron and dexamethasone in patients undergoing middle ear surgery. Br J Anaesth. 1998 Nov;81(5):754-6. doi: 10.1093/bja/81.5.754.
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Fujii Y, Saitoh Y, Tanaka H, Toyooka H. Anti-emetic efficacy of prophylactic granisetron compared with perphenazine for the prevention of post-operative vomiting in children. Eur J Anaesthesiol. 1999 May;16(5):304-7. doi: 10.1046/j.1365-2346.1999.00483.x.
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Gombar S, Kaur J, Kumar Gombar K, Dass A, Singh A. Superior anti-emetic efficacy of granisetron-dexamethasone combination in children undergoing middle ear surgery. Acta Anaesthesiol Scand. 2007 May;51(5):621-4. doi: 10.1111/j.1399-6576.2007.01296.x.
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Long DR, Lihn AL, Friedrich S, Scheffenbichler FT, Safavi KC, Burns SM, Schneider JC, Grabitz SD, Houle TT, Eikermann M. Association between intraoperative opioid administration and 30-day readmission: a pre-specified analysis of registry data from a healthcare network in New England. Br J Anaesth. 2018 May;120(5):1090-1102. doi: 10.1016/j.bja.2017.12.044. Epub 2018 Mar 9.
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Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247.
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Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.
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Smith I, Terhoeve PA, Hennart D, Feiss P, Harmer M, Pourriat JL, Johnson IA. A multicentre comparison of the costs of anaesthesia with sevoflurane or propofol. Br J Anaesth. 1999 Oct;83(4):564-70. doi: 10.1093/bja/83.4.564.
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Smith I, Thwaites AJ. Target-controlled propofol vs. sevoflurane: a double-blind, randomised comparison in day-case anaesthesia. Anaesthesia. 1999 Aug;54(8):745-52. doi: 10.1046/j.1365-2044.1999.00953.x.
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Fleischmann E, Akca O, Wallner T, Arkilic CF, Kurz A, Hickle RS, Zimpfer M, Sessler DI. Onset time, recovery duration, and drug cost with four different methods of inducing general anesthesia. Anesth Analg. 1999 Apr;88(4):930-5. doi: 10.1097/00000539-199904000-00046.
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Fredman B, Nathanson MH, Smith I, Wang J, Klein K, White PF. Sevoflurane for outpatient anesthesia: a comparison with propofol. Anesth Analg. 1995 Oct;81(4):823-8. doi: 10.1097/00000539-199510000-00028.
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Shakir AAK, Ramachandra V, Hasan MA. Day surgery postoperative nausea and vomiting at home related to preoperative fentanyl. J One-day Surg 1997;6:10-1.
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Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
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Vandermeulen EP. Controlling the stress response. In: White PF (ed). Textbook of Intravenous Anesthesia. Baltimore: Williams & Wilkins; 1997. p. 565-79.
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Borgeat A, Wilder-Smith OH, Saiah M, Rifat K. Subhypnotic doses of propofol possess direct antiemetic properties. Anesth Analg. 1992 Apr;74(4):539-41. doi: 10.1213/00000539-199204000-00013.
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Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
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Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
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Other Identifiers
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050108073(18/12/2018)
Identifier Type: -
Identifier Source: org_study_id
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Patient Knowledge on Pain Management and Safe Opioid Use
NCT04498559
COMPLETED