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Multimodal Postoperative Analgesia Following OSA Surgery

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine, ketorolac, accufuser
Sponsored by
Bahaa Mohammed Refaie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • physical status of American Society of Anesthesiologists (ASA) II
  • age between 30 - 50 years
  • OSA patients diagnosed by polysomnography and stop-bang questionnaire
  • enrolled for multilevel OSA surgery

Exclusion Criteria:

  • history of allergy to the study drugs
  • history of hepatic, cardiopulmonary or renal disease
  • history of any chronic pain on medication
  • history of substance abuse
  • psychiatric disorder
  • lack of patient cooperation.

Sites / Locations

  • Sohag faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OSA patients after multilevel surgery

Arm Description

Outcomes

Primary Outcome Measures

Postoperative pain
visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score
Postoperative pain
Visual analog pain score

Secondary Outcome Measures

Sedation level
Ramsey sedation scale
Sedation level
Ramsey sedation scale
Sedation level
Ramsey Sedation Scale
Sedation level
Ramsey Sedation Scale
Sedation level
Ramsey Sedation Scale
Sedation level
Ramsey Sedation scale
Sedation level
Ramsey Sedation Scale
Sedation level
Ramsey Sedation Scale
Sedation level
Ramsey Sedation Ramsey Sedation Scale
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching
incidence of adverse effects
hypoxia, nausea, vomiting, itching

Full Information

First Posted
July 16, 2020
Last Updated
September 26, 2021
Sponsor
Bahaa Mohammed Refaie
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1. Study Identification

Unique Protocol Identification Number
NCT04483427
Brief Title
Multimodal Postoperative Analgesia Following OSA Surgery
Official Title
Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bahaa Mohammed Refaie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OSA patients after multilevel surgery
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
Nalbuphine, ketorolac, accufuser
Intervention Description
multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)
Primary Outcome Measure Information:
Title
Postoperative pain
Description
visual analog pain score
Time Frame
Assessment will be carried out at zero time (time to shift to PACU) .
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 6 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 12 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 18 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 24 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 30 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 36 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 42 hours postoperatively
Title
Postoperative pain
Description
Visual analog pain score
Time Frame
Assessment will be carried out 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Sedation level
Description
Ramsey sedation scale
Time Frame
Zero time ( time to shift to PACU)
Title
Sedation level
Description
Ramsey sedation scale
Time Frame
6 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Scale
Time Frame
12 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Scale
Time Frame
18 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Scale
Time Frame
24 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation scale
Time Frame
30 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Scale
Time Frame
36 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Scale
Time Frame
42 hours postoperatively
Title
Sedation level
Description
Ramsey Sedation Ramsey Sedation Scale
Time Frame
48 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
Zero time ( time to shift to PACU)
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
6 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
12 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
18 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
24 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
30 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
36 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
42 hours postoperatively
Title
incidence of adverse effects
Description
hypoxia, nausea, vomiting, itching
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: physical status of American Society of Anesthesiologists (ASA) II age between 30 - 50 years OSA patients diagnosed by polysomnography and stop-bang questionnaire enrolled for multilevel OSA surgery Exclusion Criteria: history of allergy to the study drugs history of hepatic, cardiopulmonary or renal disease history of any chronic pain on medication history of substance abuse psychiatric disorder lack of patient cooperation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahaa M Refaie, MD
Phone
0201026887257
Email
bahaarefaay@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahaa M Refaie, MD
Organizational Affiliation
Lecturer of anesthesia and ICU sohag university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed E Ahmed, MD
Organizational Affiliation
Lecturer of ENT sohag university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A M Elhalwagy, MD
Organizational Affiliation
Consultant of pain medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Sohag faculty of medicine
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahaa M Refaie, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Multimodal Postoperative Analgesia Following OSA Surgery

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