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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05133375
Other study ID # 11112021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date October 1, 2021

Study information

Verified date November 2021
Source CMH Jhelum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A total of 272 patients were randomly allocated into two groups, Patients in group A were treated with Macintosh laryngoscope and in groups B with McCoy laryngoscope was used for endotracheal intubation. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Pro forma.


Description:

After taking approval from hospital ethical committee, 272 patients who reported to Operation Theatre of CMH, Jhelum were selected for the study. Informed consent was obtained and patient demographic information (name, age, contact) was recorded. Patients were randomly divided in two equal groups by using lottery method. GROUP A: Where Macintosh laryngoscope was used for endotracheal intubation. GROUP B: Where McCoy laryngoscope was used for endotracheal intubation. Before reporting to Operation theatre a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Proforma.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date October 1, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Both Male and Female - Age between 18 to 70 - ASA I and II males and females. - Malampatti I and II. - Hemodynamically stable, no known ischemic heart disease and no history of hypertension. - Nil per oral for at least 6 hours. Exclusion Criteria: - Non consenting patient. - ASA III, IV or V patient. - Malampati III or IV. - Cervical instability - Thyromental distance of less than 6cm, inter incisor distance of less than 3cm. - Known case of hypertension and ischemic heart disease. - Pregnant female. - Body mass index of more than 30. - Patients of oropharyngeal surgery. - Unable to Intubate in less than 1 minute.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tracheal Intubation
Before reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.

Locations

Country Name City State
Pakistan CMH Jhelum Punjab

Sponsors (1)

Lead Sponsor Collaborator
CMH Jhelum

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect on the pulse of intubation with Macintosh and McCoy laryngoscope To measure hemodynamic changes (i.e. pulse) of intubation with Macintosh and McCoy laryngoscope After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
Primary Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope To measure hemodynamic changes (i.e. systolic blood pressure) of intubation with Macintosh and McCoy After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation
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