The objective of the study is to compare the incidence of airway related complications when using nasal packing versus septal stitch post-operatively in patients presenting for elective septoplasty for deviated nasal septum (DNS)
Design
A randomised controlled trial ; single study center with two interventional groups carried out from June 23 to Dec 23 , with sample size of 110 individuals in each group.
Settings and conduct
The study was conducted in Anesthesia department of combined military hospital rawalpindi, with randomized controlled method, non blind. The sampling was done by non probability consecutive sampling via lottery method and resident o duty marked the groups with X and Y chits. Patients of group marked with X chits were allocated septal stich group and patients with group marked Y chit were allocated nasal packing group.
Participants/Inclusion and exclusion criteria
The inclusion criteria included all patients >18 years presenting for pre-anesthesia assessment for elective nasal surgeries requiring nasal packing/septal stitch post-operatively.
The exclusion criteria included patients < 18 years, pregnancy, previous history of septoplasty, patients with coagulation disorders, patients with advanced cardiac, respiratory, or metastatic disease, patients with concomitant nasal surgery including turbinectomy etc. and patients unwilling to be included in the study or lost to follow-up.
Intervention groups
The patients were randomized into two groups of 110 patients each. Group N (n=110) to receive nasal packing and Group S (n=110) to receive septal sutures.
Main outcome variables
Main variables were followings
1. Time from recovery room to discharge
2. Median pain scores in recovery
3. Mean dose of analgesia post procedure in recovery room before discharge
4. Laryngospam
5. Hypoxia
6. Bleeding
7. Headache
8. Sleep disturbances
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060756N1
Registration date:2024-06-13, 1403/03/24
Registration timing:retrospective
Last update:2024-06-13, 1403/03/24
Update count:0
Registration date
2024-06-13, 1403/03/24
Registrant information
Name
Muhammad Asif Hayat
Name of organization / entity
Combined military hospital rawalpindi
Country
Pakistan
Phone
+92 301 3171974
Email address
asifhayat577@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-12-10, 1402/09/19
Actual recruitment start date
2023-06-15, 1402/03/25
Actual recruitment end date
2023-12-15, 1402/09/24
Trial completion date
2023-12-15, 1402/09/24
Scientific title
Comparison of nasal packing versus septal stitches on airway complications during recovery from anesthesia
Public title
Benefits of septal stitches over nasal packing during recovery from general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included all patients >18 years presenting for pre-anesthesia assessment for elective nasal surgeries requiring nasal packing/septal stitch post-operatively.
Exclusion criteria:
Included patients < 18 years, pregnancy, previous history of septoplasty, patients with coagulation disorders, patients with advanced cardiac, respiratory, or metastatic disease, patients with concomitant nasal surgery including turbinectomy etc. and patients unwilling to be included in the study or lost to follow-up.
Pregnant patients
Previously history of septoplasty
Coagulation disorders
Cardiac diseases
Respiratory diseases
Unwilling for study
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomisation in both groups was done using lottery method. The unit of randomization was individual. At the day of surgery, before going to the operating room, all patients were asked to select envelopes prepared by a resident Anesthetist marked X and Y. Allocation concealment from the resident was done and only the consultant in the operating room was aware that patients in X were to undergo septal stitch and Y to undergo nasal packing
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
CMH ethical review board
Street address
Tamiz uddin road Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
ERB.549 ethical review board of combined military hospital rawalpindi
Health conditions studied
1
Description of health condition studied
Airways complications in nasal packing versus stiches
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Airways complications in bilateral nasal packing versus septal stitches during recovery from general anesthesia
Timepoint
6 hours from post anesthesia recovery unit
Method of measurement
Visual analogue score , pulse oximeter for saturation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nasal packing group; vaseline soaked Nasal packing done during general anesthesia in septoplasty patients for mechanical to readjusted septum , to reduce bleeding .
Category
Treatment - Other
2
Description
Intervention group: Septal stitches group , quilted stitches applied to reduce incidence of airway complications, laryngospam, decrease bleeding, hematoma formation, hypoxia, good recovery with decreased healing time .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined military hospital
Full name of responsible person
Dr Muhammad Asif Hayat
Street address
Tamizudin Road, rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273423
Email
Asifhayat577@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Ghulam Sabir
Street address
Tamizudin Road rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 300 4636104
Email
Asifhayat577@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined military hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Muhammad Asif Hayat
Position
Post graduate resident anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tamizudin Road rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 301 3171974
Email
Asifhayat577@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Muhammad Asif Hayat
Position
Post graduate resident anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tamizudin Road rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 301 3171974
Email
Asifhayat577@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined military hospital
Full name of responsible person
Dr Muhammad Asif Hayat
Position
Post graduate resident of anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Tamizudin Road rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
4600
Phone
+92 301 3171974
Email
Asifhayat577@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data could be provided
When the data will become available and for how long
Data will be available for two years starting from July 2023 to July 2025
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Intervention studies being done on the same topic
From where data/document is obtainable
asifhayat577@gmail.com
What processes are involved for a request to access data/document
Can contact to email (asifhayat577@gmail.com ) for detailed data .