Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia

NCT06265948 | Not Yet Recruiting

• 1 other identifier: comparsion drugs in cancer
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries )

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• post operative pain

  pain according to VAS score

  two hours

Study Arms (1)

The sample will be randomly assigned into one of two equal groups ((Group-I (n

Sample size calculation was carried out using G\*Power 3 software (Faul et al., 2007)1 calculated minimum sample of 80 patient candidate for cancer surgery will be needed. The sample will be randomly assigned into one of two equal groups ((Group-I (n=40): will receive standard general anesthesia as control, and Group III (n=40): will receive Ketofol in addition to the standard general anesthesia. The calculated sample will be needed to detect an effect size of 0.1 in the RM-ANOVA (within group-between groups and interaction) on repeated measurements (every 2-hours postoperatively) for the mean VAS score, with an error probability of 0.05 and 95% power.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 Exclusion Criteria: * a. Inclusion criteria: 1. Age group 18 - 60 years old. 2. Both gender 3. ASA 1and 2 b. Exclusion criteria: <!-- --> 1. Patient refusal, 2. History of cardiac or respiratory disease, psychological disorders, 3. High risk of regurgitation or aspiration based on a history of diabetes, hiatus hernia, gastroesophageal reflux, and obesity, 4. neck pathology, 5. Predicted difficult airway (history of difficult airway, mouth opening

You may qualify if:

• Age group 18 - 60 years old.
• Both gender
• ASA 1and 2

You may not qualify if:

• Age group 18 - 60 years old.
• Both gender
• <!-- -->
• Patient refusal,
• History of cardiac or respiratory disease, psychological disorders,
• High risk of regurgitation or aspiration based on a history of diabetes,
• hiatus hernia, gastroesophageal reflux, and obesity,
• neck pathology,
• Predicted difficult airway (history of difficult airway, mouth opening

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

khaled Hussien

CONTACT

01029314432; kh1357kha@gmail.com

Essam Manaa

CONTACT

‪+20 102 446 6633‬; essam.manaa@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02