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

NCT ID: NCT06005701

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 470 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-09-30

Brief Summary

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

Detailed 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.

Conditions

Mallampati Score; Difficult Intubation; Patient Satisfaction; Cholestasis; Cholecystitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abaalkhayl

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qassim University Medical City

Buraidah, Al-Qassim Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

23-33-05

Identifier Type: -

Identifier Source: org_study_id