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NCT06005701 Clinical Trial

Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

Patient Satisfaction Clinical Trial

Official title:
Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06005701
Other study ID # 23-33-05
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date September 30, 2023

Study information
Verified date August 2023
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

Description:

A preoperative assessment by anaesthetic staff should include the Mallampati Score, as there is a direct correlation between the amount of space in the pharynx and the laryngoscopic view during intubation which has been refined by Cormack and Lehane (1984) Clinical diagnosis one of most important factor indicating the postoperative complications like Mallampati score. As the Mallampati class zero per se is not indicating with any difficulty of airway management unless other airway characteristics indicating to the difficulty. As well as if the epiglottis may be large and overhanging, it's not common with airway difficulty in Mallampati class zero airway. The Mallampati score idea is to estimate the size of the tongue related to the oral cavity and the displacement of the tongue by the laryngoscope blade was likely to be easy or difficult. It also assessed whether the mouth could be opened adequately to permit intubation Research objectives To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery. Method: Observational, Multi hospital, Regional Study Inclusion Criteria: 1. Age: 20 - 50 years 2. Laparoscopic Cholecystectomy Surgery 3. Body Mass Index (BMI): ≤ 35 Exclusion Criteria: 1. Age Less than 20 years 2. Age More than 50 years 3. Body Mass Index (BMI) > 35 Data management and analysis plan: All data will be entered and analyzed using SPSS V28© (IBM Corp., Armonk, NY, USA). Categorical variables will have expressed as frequencies and percentages, while continuous variables will have presented as means ± standard deviations (SDs). The chi-squared test will have used to evaluate demographic and health-related characteristics associated with name of the clinic as well as type of service provided to the patient. A p-value of less than 0.05 was considered to be statistically significant Ethical considerations: - All investigators completed the Bioethics certificate from The National Committee of Bioethics at King Abdulaziz City for Science and Technology. - All investigators declare there is no conflict of interest.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 470
Est. completion date September 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: 1. Age: 20 - 50 years 2. Laparoscopic Cholecystectomy Surgery 3. Body Mass Index (BMI): = 35 Exclusion Criteria: 1. Age Less than 20 years 2. Age More than 50 years 3. Body Mass Index (BMI) > 35

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Saudi Arabia Qassim University Medical City Buraidah Qassim

Sponsors (1)
Lead Sponsor Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surveillance predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery. 3 months
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