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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05040022
Other study ID # CAAE 49753621.1.0000.5373
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2021
Est. completion date January 15, 2022

Study information

Verified date September 2021
Source Pontificia Universidade Catolica de Sao Paulo
Contact Eduardo Moro
Phone 15997728015
Email edumoro85@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of low-pressure pneumoperitoneum seems to be able to reduce complications such as postoperative pain. However, the quality of evidence for most studies evaluating this relationship is considered low. The absence of concealment of pneumoperitoneum pressure and the lack of description of neuromuscular blockade characteristics are the main causes of bias. The purpose of this study will be to evaluate by means of a prospective, randomized and double-blinded trial, the quality of recovery (QoR-15) questionnaire of patients undergoing laparoscopic cholecystectomy under moderate neuromuscular blockade, using low pneumoperitoneum pressure or "standard" pressure. Eighty patients submitted to laparoscopic cholecystectomy and randomly distributed in two groups will be included: low pneumoperitoneum pressure (10 mmHg) or "standard" pressure (14 mmHg). The value of abdominal pressure will be kept hidden for all participants, except for the nurse responsible for the operating room. Moderate neuromuscular blockade will be maintained according to Train-of-four count (TOFc) = 3 for all cases.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pneumoperitoneum pressure 10 mmHg
The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 10 mmHg (group 10)
Pneumoperitoneum pressure 14 mmHg
The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 14 mmHg (group 14).

Locations

Country Name City State
Brazil Eduardo T Moro Araçoiaba da Serra SP

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidade Catolica de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of recovery The quality of recovery will be assessed using the Qualtity of Recovery 15
questionnaire. Total scores range from 0 to 150. Higher scores mean a better outcome.
From randomization up to 15 days
Secondary Postoperative pain Pain intensity (Verbal Numeric Scale) will be assessed at 15, 30, 45 and 60 minutes during postanesthetic unit (PACU) stay and 4, 8, 12 and 24 hours after arrival on the ward.Verbal Numeric Scale scores range from 0 to 10. Higher scores mean a worse outcome. From the PACU arriving up to 24 hours
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