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Opioid Free Anesthesia in Obese Patients.

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ClinicalTrials.gov Identifier: NCT05481970
Recruitment Status : Not yet recruiting
First Posted : August 1, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Rana Ahmed Abdelghaffar, Fayoum University Hospital

Tracking Information
First Submitted Date  ICMJE July 20, 2022
First Posted Date  ICMJE August 1, 2022
Last Update Posted Date August 31, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2022)
  • Attacks of postoperative pain with vas score ≥4 [ Time Frame: 24 hours postoperative ]
    The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, postoperative pain with vas score ≥4 will be monitored and recorded
  • rescue doses of tramadol [ Time Frame: 24 hours postoperative ]
    time of rescue doses of tramadol
  • how many rescue doses of tramadol [ Time Frame: 24 hours postoperative ]
    number of rescue doses of tramadol
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2022)
  • Hypoxia [ Time Frame: every 2hours for 24 hours. ]
    number of patients with hypoxia (an Spo2 level of less than 95%)
  • Postoperative nausea and vomiting. [ Time Frame: 24 hours postoperative ]
    Postoperative nausea and vomiting( number of attacks)
  • Postoperative usage of antiemetics [ Time Frame: 24 hours postoperative ]
    number of patients who will need rescue dose of antiemetic medication.
  • Intraoperative bradycardia [ Time Frame: intraoperative ]
    number of patients who will develop intra-operative bradycardia HR≤50bpm,
  • Intraoperative hypotension [ Time Frame: intraoperative ]
    number of patients who will develop intra-operative hypotension mean arterial blood pressure ( mABP) ≤60 millimetre of mercury (mmHg)
  • Intraoperative hypertension [ Time Frame: intraoperative ]
    number of patients who will develop intra-operative hypertension mABP ≥90mmHg).
  • ICU admission. [ Time Frame: 24 hours postoperative ]
    number of participants who will need intensive care unit
  • extubation time [ Time Frame: 60 minutes after cessation of anesthesia ]
    time when endotracheal tube removed from the patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Free Anesthesia in Obese Patients.
Official Title  ICMJE Opioid Free Anesthesia for Upper Limb Surgery in Obese Patients.
Brief Summary

Using opioids in the clinical practice of anesthesia was astonishing. They are good analgesics and used widely to modulate perioperative pain, but analgesia with these drugs can be associated with many side effects that may lead to prolongation of hospital stay and recovery period like respiratory depression, delirium, impaired gastrointestinal function, urine retention, post-operative nausea and vomiting (PONV), and addiction. The most significant opioid side effect is respiratory depression. This is especially important in patients suffering from obesity. Obese patients already have a restrictive lung disease leading to decrease in functional residual capacity and total lung compliance. Anesthetics and analgesics specially opioids make these respiratory problems become worse with increasing the incidence of hypoxia. These side effects can be avoided by using opioid free anesthesia (OFA) techniques.

Opioid free anesthesia recently become more applicable and popular in different centers, it provides pain control with marked reduction in opioid consumption. However, researches and studies still unable to explore definite explanations or techniques regarding it. The base of OFA is that not only one drug can replace opioids. It is a multimodal anesthesia. Multiple drugs are used to achieve it. They are hypnotics,N-methyl-D-aspartate (NMDA) antagonists (ketamine, magnesium sulfate), sodium channel blockers (local anesthetics), anti-inflammatory drugs (NSAID, dexamethasone), and alpha-2 agonists (dexmedetomidine, clonidine). Regional anesthesia and nerve blocks also have a role. In this study, using OFA the investigators are hoping to achieve a good quality of care to obese patients helping in fast track surgery with less complications and so shorter period of hospital stay

Detailed Description

Patients will be randomly allocated (by closed envelope method) to two groups:

Group A (n=38) will have opioid free anesthesia (OFA) Group B (n=38) will have opioid based anesthesia (OPA) All patients will be subjected to a preoperative clinical examination and routine preoperative laboratory investigations. Patients also will be trained on how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score using a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(9,10) In the operating room (OR), peripheral oxygen saturation (spo2), noninvasive blood pressure and electrocardiogram ( ECG) will be monitored and recorded as a baseline reading. A peripheral intravenous cannula will be inserted t hen patients in both groups will receive 1mg of midazolam prior induction of anesthesia. Preoxygenation 3-5 minutes before induction will be done. Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction. In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.

All Patients will be mechanically ventilated with 50% O2 and 50% air and the end-tidal carbon dioxide( CO2) will be maintained between 30 - 35 mmHg. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Reversal of muscle relaxants will done by using intravenous neostigmine (0.05 mg/kg) and atropine (0.01 mg/kg) at the end of surgery and the patient will be extubated when the patient will be able to breath spontaneously with tidal volume ≥5ml/kg and spo2>92%. Paracetamol 1gm i.v. infusion and ketorolac 30 mg slow i.v injection will be used at the end of surgery and before emergence in both groups. At the recovery room, patients will assess their pain and rating it using VAS score, monitored for postoperative pain, the patients will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (11) Any patient with Vas score ≥4, will receive tramadol 1mg/kg i.v. with a maximum dose 600mg/day.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Opioid Free Anesthesia
Intervention  ICMJE
  • Drug: dexmedetomidine,ketamine,lidocaine,propofol
    Group (A): Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction.
    Other Name: dexamethasone
  • Drug: fentanyl,propofol
    In group (B) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.
    Other Name: fentanyl
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine group
    Group A , Induction of general anesthesia will be done using lidocaine (1.5 mg/kg), propofol (2-3 mg/kg), and atracurium (0.5 mg/kg). Dexmedetomidine 0.5 µg/kg over 10 min, started 10 min before induction. Following tracheal intubation, dexmedetomidine infusion generally will be initiated at 0.6 μg/kg/h and titrated between 0.2 and 1.0 μg/kg/h according to the heart rate maintaining bispectral index (BIS) between 40-60, lidocaine (1.5 mg/kg/h). ketamine will be given as a bolus dose of 0.3 mg/kg after induction and prior to skin incision then 0.2 mg/kg/h as an infusion. Patients will receive dexamethasone (8 mg i.v.) after induction.
    Intervention: Drug: dexmedetomidine,ketamine,lidocaine,propofol
  • Placebo Comparator: Opioid group
    In group (B) (OBA) for induction of anesthesia, patients will receive propofol 2-3mg/kg, fentanyl 1-2mcg/kg and atracurium 0.5 mg/kg as a muscle relaxant to facilitate intubation. Fentanyl bolus doses of 0.5-1 mcg/kg will be given to keep BIS score 40-60 during surgery.
    Intervention: Drug: fentanyl,propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2022)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) physical status Ⅱ , Ⅲ.
  • body mass index (BMI) ≥30 kg/m2.
  • Have upper limb surgeries (orthopedics, plastic,…) under general anesthesia.

Exclusion Criteria:

  • Known allergy to the drugs will be used in the study.
  • Pregnancy and lactation.
  • Addiction or recent use of opioids'
  • Patients will not be able deal with visual analog score(VAS).
  • Hepatic, Renal and cardiac diseases in advanced stages.
  • History of epilepsy or seizures.
  • Patients with cerebrovascular disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rana A Abdelghaffar, MD 01002360634 ext +20 rona0022@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05481970
Other Study ID Numbers  ICMJE opioid free anesthesia
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Rana Ahmed Abdelghaffar, Fayoum University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fayoum University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rana A Abelghaffar, MD Faculty of medicine , Fayoum university
PRS Account Fayoum University Hospital
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP