UMIN-CTR Clinical Trial

Public title

The effects of pneumoperitoneum with carbon dioxide insufflation on forehead skin and cerebral blood flows in patients undergoing gynecological laparoscope assisted surgery

Acronym

Carbon dioxide overexposure itself spare skin and brain blood flows?

Scientific Title

The effects of pneumoperitoneum with carbon dioxide insufflation on forehead skin and cerebral blood flows in patients undergoing gynecological laparoscope assisted surgery

Scientific Title:Acronym

Carbon dioxide overexposure itself spare skin and brain blood flows?

Region

Japan

Condition

gynecological laparoscope assisted surgery

Classification by specialty

Operative medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Facial skin blood flow basically increases during Trendelenburg position (TP). Pneumoperitoneum with CO2 insufflation reportedly increases in peripheral vascular resistance. But, It remains unknown if facial blood flow decreases during pneumoperitoneum with TP or not. This study examined this issue, especially seeking the role of CO2 catalysis, in patients undergoing gynecological laparoscope assisted surgeries conducted with inhalational anesthesia.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The main study observed changes in forehead skin blood flow measured by the laser flowmeter together with cerebral oxymetry (rsO2) at the 9 measuring points including start of surgery, just after start of pneumoperitoneum, just pre- and post TP (-15 degree), 10 and 20 minutes after TP, just pre- and post-postural change, and end of surgery. The supplement study compared the changes in them together with forehead skin temperature between patients pretreated with acetazolamide 5 mg/kg IV and placebo at the commencement of anesthesia.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Female

Key inclusion criteria

Patients with ASA physical status I and II undergoing gynecological laparoscope assisted surgeries for benign diseases (myoma uteri, ovarian tumor and cysts) were enrolled.

Key exclusion criteria

Excluded criteria were patient's body mass index (BMI)>35 or <18, and patients with diabetes mellitus, hypertension, collagen diseases, skin diseases, and allergies to foods or drugs.

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Iranami

Organization

Japanese Red Cross Society Wakayama Medical Center

Division name

Department of anesthesiology

Zip code

Address

Komatusbara 4-20, Wakayama city, Wakayama Pref

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Japanese Red Cross Society Wakayama Medical Center

Division name

Department of anesthesiology

Zip code

Address

073-422-4171

TEL

Homepage URL

Email

Institute

Japanese Red Cross Society Wakayama Medical Center

Institute

Department

Personal name

Organization

Japanese Red Cross Society Wakayama Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Forehead skin blood flow and rsO2 of both sides significantly decreased after the start of pneumoperitoneum. Significantly further decrease in the former but not the latter was observed during TP.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Suspended

Date of protocol fixation

2011

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The pretreatment with acetazolamide significantly decreased in the forehead skin blood flow and superficial skin temperature. rsO2 of both sides did not show any significant changes at every point in patients treated with acetazolamide.

Registered date

2011

Year

05

Month

08

Day

Last modified on

2011

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006595