Protocol summary

Study aim
The effect of pulmonary recruitment maneuver and supplemental oxygen therapy and their combination on shoulder pain, nausea, and vomiting in patients undergoing laparoscopic cholecystectomy
Design
100 patients will be randomly divided into four groups A, B, C, D, with a ratio of 1:1:1:1. The main researcher (anesthesiologist) has been working for 10 years and has complete mastery of both of these methods; This technique will be performed under the supervision of an anesthesiologist and a surgeon.
Settings and conduct
In the operating room of Arefian Hospital in Urmia, shoulder pain will be assessed using VAS tools in 4, 12, and 24 hours after surgery in all groups. Rhodes-induced nausea and vomiting will be assessed in 12 and 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with anesthesia class one and two in the age range of 35 to 55 years and no underlying diseases and nausea and vomiting, non-smoking / Exclusion conditions: Patients with intra-abdominal pressure more than 14 mm Hg, receiving anti-inflammatory drugs Vomiting, infectious infection of the peritoneal cavity, and adhesions, change of surgical procedure to laparotomy, underlying disease, smoking
Intervention groups
combined method group (A), two interventions of pulmonary recruiting maneuvers with complementary oxygen therapy will be performed. In the pulmonary recruiting group (B), the ventilator airway pressure relief valve will close to fill the bag. Then five manual breaths will be given. For supplemental oxygen therapy group (C), the moment the patient enters the ward until 6 hours later, oxygen will be administered through the nasal cannula 4 lit/min. In the control group (D), the usual procedure will be performed by applying gentle abdominal pressure to remove CO2 through the port site at the end of surgery.
Main outcome variables
Shoulder pain and nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211013052762N1
Registration date: 2021-11-18, 1400/08/27
Registration timing: prospective

Last update: 2021-11-18, 1400/08/27
Update count: 0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
hamed tayyeb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3276 2050
Email address
hamed7197@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of the application of pulmonary recruitment maneuver and supplemental oxygen therapy and their combination on shoulder pain and nausea and vomiting in patients undergoing laparoscopic cholecystectomy in the Shahid Arefian Hospital of Urmia
Public title
comparing the effect of the application of pulmonary recruitment maneuver and supplemental oxygen therapy and their combination on shoulder pain and nausea and vomiting in patients undergoing laparoscopic cholecystectomy in the Shahid Arefian Hospital of Urmia city in 2021
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anesthesia class one and two and can communicate verbally Patients in the age range of 35 to 55 years Candidate for elective laparoscopic cholecystectomy with general anesthesia No chronic obstructive pulmonary, renal, hepatic, cardiac, gastrointestinal and cerebral diseases No history of diseases causing nausea and vomiting No electrolyte disturbance No motion sickness No smoking
Exclusion criteria:
Patients whose intra-abdominal pressure is more than 14 mm Hg during surgery. No concomitant non-laparoscopic surgery Receive antiemetic drugs before and after surgery Peritoneal cavity infection Hemoperitoneum and multiple adhesions in the peritoneum and peripheral when surgical procedure changed to laparotomy. Having a history of laparotomy Having any underlying disease Smoking
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation with a ratio of 1: 1: 1: 1 will be divided into four groups: pulmonary record, complementary oxygen therapy, combined method (pulmonary record and complementary oxygen therapy), and control using the secure envelope method. In this way, inside the envelopes, closed sheets will contain all four approaches with equal proportions and sample volumes. Before starting the interventions, a person not related to the research will randomly select one of the sheets. Moreover, the patient will subsequently be assigned to that group. Due to the nature of the study, the patient will not know which group will be assigned. Also, when analyzing the data, the groups will be provided to the statistical analyst anonymously with the English letters A, B, C, and D; Therefore, the study will be double-blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study will be a double-blind, four-group, 2 * 2 factorial design clinical trial.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia university of medical sciences
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.UMSU.REC.1400.249

Health conditions studied

1

Description of health condition studied
Cholelithiasis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis

Primary outcomes

1

Description
Shoulder pain
Timepoint
In recovery, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
12 and 24 hours after surgery
Method of measurement
Rhodes scale

Intervention groups

1

Description
The first intervention group: in the combined method group (group A), a combination of two interventions of pulmonary recruitment maneuver combined with complementary oxygen therapy.
Category
Treatment - Other

2

Description
Intervention group 2: In pulmonary recruiting group (group B), the air pressure relief valve will be closed on the ventilator to fill the bag. Then five manual breaths will be given for each breath for 5 seconds.
Category
Treatment - Other

3

Description
Intervention group: Intervention group 3: For the supplemental oxygen therapy group (group C), routine surgical interventions will be performed and from the moment the patient enters the ward until 6 hours later, 2 to 4 liters of oxygen per minute will be prescribed for the patient.
Category
Treatment - Other

4

Description
Control group: In the control group (group D), the usual procedure will be performed by applying gentle abdominal pressure to remove CO2 through the port at the end of surgery.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arefian Hospital
Full name of responsible person
Yaser moradi
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
yasermoradi1045@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yaser Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
yasermoradi1045@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yaser Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
yasermoradi1045@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamed Tayeb
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Resalat Boulevard, Emergency Alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hamed7197@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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