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Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285255
Recruitment Status : Completed
First Posted : February 26, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Al Mashfa Medical Center

Tracking Information
First Submitted Date  ICMJE February 22, 2020
First Posted Date  ICMJE February 26, 2020
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE March 1, 2020
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
Quality of recovery 40 questionnaire (QoR-40) [ Time Frame: 24 hours ]
postoperative quality of recovery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • Pethidine consumption [ Time Frame: 24 hours ]
  • Numerical rating scale (NRS) [ Time Frame: 24 hours ]
    visual analogue scale postoperatively
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 Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy
Official Title  ICMJE Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial
Brief Summary Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
only the anaesthetist is one aware of the study groups
Primary Purpose: Treatment
Condition  ICMJE
  • Narcotics
  • Recovery Quality
  • Analgesia
  • Bariatric Surgery
Intervention  ICMJE
  • Drug: Fentanyl
    opioids anaesthesia
  • Drug: Ketamine
    ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
  • Drug: Dexmedetomidine Injection [Precedex]
    alpha 2 agonist with sedative, analgesic effect
  • Procedure: Oblique subcostal transversus abdominis plane block
    Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
  • Drug: Lidocaine
    infusion of lidocaine 2%(1mg/kg/h)
Study Arms  ICMJE
  • Active Comparator: Opioids anesthesia
    received propofol-fentanyl induction of anaesthesia plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
    Interventions:
    • Drug: Fentanyl
    • Procedure: Oblique subcostal transversus abdominis plane block
  • Active Comparator: OFA
    received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
    Interventions:
    • Drug: Ketamine
    • Drug: Dexmedetomidine Injection [Precedex]
    • Procedure: Oblique subcostal transversus abdominis plane block
    • Drug: Lidocaine
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2020)
103
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2020)
70
Actual Study Completion Date  ICMJE August 1, 2020
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 70 ASA II - III adult patients (18-60 years old)
  • Elective laparoscopic bariatric surgery.
  • Body mass index (BMI) is from 40 to 60
  • Trocar sites at or above the umbilicus (T 10 dermatome).

Exclusion Criteria:

  • Allergy to amino-amide local anaesthetics,
  • presence of coagulopathy
  • local skin infection at injection sites,
  • preoperative chronic dependence upon opioid and NSAID medications,
  • liver or renal insufficiency,
  • history of psychiatric or neurological disease, deafness,
  • previous open surgery,
  • patients who need to be converted to open surgery with more tissue trauma,
  • ASA (American society of anesthesiologists) class above III were excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04285255
Other Study ID Numbers  ICMJE OFA
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 Not Provided
Responsible Party Al Mashfa Medical Center
Study Sponsor  ICMJE Al Mashfa Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Al Mashfa Medical Center
Verification Date March 2020

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