Trial no.:	PACTR202009470667596	Date of Registration:	30/09/2020
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Ventilation strategy to reduce post operative pain in laparoscopic surgery

Official scientific title

Ventilation strategy to reduce post operative pain in laparoscopic surgery, recruitment maneuver versus extended hyperventelation: A prospective randomized controlled trial.

Brief summary describing the background and objectives of the trial

Cholecystectomy is one of the most commonly performed abdominal surgical procedures. The etiology of pain after laparoscopic surgery is multifactorial , acid milieu and systemic absorption created by the dissolution of CO2 gas cause peritoneal irritation and phrenic nerve damage. so, trials done to washout co2 and release this effect.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

recruitment maneuver

Disease(s) or condition(s) being studied

Anaesthesia

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

20/09/2020

Actual trial start date

Anticipated date of last follow up

27/10/2020

Actual Last follow-up date

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	extended hyper ventilation	hyper ventilation to keep end tidal co2 target 30±2	during intraoperative time	ventelation using volume control ventilation, with extended hyper ventilation keeping end tidal co2 target 30±2	30	Active-Treatment of Control Group
Experimental Group	Pulmonary recruitment maneuver	6 times within 2 minutes, each cycle hold breathing for 10 sec and relief for 10 sec	2 min	after completion of surgical procedure and genttle abdominal desuflation, Pulmonary recruitment maneuver will be done with vital capacity (35 cm h2o) hold for 10 second, repeated for 6 times within 2 minutes.	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
adult of both sex ASA I or II aging 18-65 years undergoing laparoscopic cholecystectomy in mansoura university hospitals	• Patient refusal • Pulmonary disease: COPD, asthma, lung bullae, cyst. • Psychological problems. • Complicated procedure	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	65 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

15/09/2020

IRB mansoura university egypt

Ethics Committee Address
Street address	City	Postal code	Country
elgomhoria street	elmansoura	35516	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	incidence of post operative shoulder or subdiaphragmatic pain	0,1,2 hours post operative
Secondary Outcome	Pain assessment (VAS)	0,1,2,4,6,12,24 hours post operative
Secondary Outcome	rescue analgesia-pethedine- consumption total dose	24 hours post operative
Secondary Outcome	post operative nausea and vometing	24 hours post operative
Secondary Outcome	HR, MABP, spo2	basal, 0,1,2,4,6,12,24 hours post operative
Secondary Outcome	po2,pco2	basal, 1 ,24 hours post operative

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
gastro entrology center	gehan street	mansoura		Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
mohamed adel aboelela	khattab street	elmansoura		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	faculty of medicine mansoura university	elgomhoria street	elmansoura	35516	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
gastro entrology surgical center	gehan street	elmansoura		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	mohamed aboelela	aboelela_mohamed@yahoo.com	00201061546753	khataab street
City	Postal code	Country	Position/Affiliation
elmansoura		Egypt	lecturer of anaesthesia and SICU mansoura university egypt
Role	Name	Email	Phone	Street address
Public Enquiries	mohamed aboelela	aboelela_mohamed@yahoo.com	00201061546753	khataab street
City	Postal code	Country	Position/Affiliation
elmansoura		Egypt	lecturer of anaesthesia and SICU mansoura university egypt
Role	Name	Email	Phone	Street address
Scientific Enquiries	aalrefaey kandeel	refa3y2@yahoo.com	00201064203475	elobour street
City	Postal code	Country	Position/Affiliation
elmansoura		Egypt	lecturer of anaesthesia and SICU mansoura university egypt

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	study design, methods ,results	Clinical Study Report,Statistical Analysis Plan,Study Protocol	12 months after completion of study	through IRB mansoura university
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry