search
Back to results

Can Head Position Improve Surgical Field During Ear Surgery?

Primary Purpose

Intra-operative Bleeding

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Head-Up Position
Dexmedetomidine
Induction and maintenance of anaesthesia
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intra-operative Bleeding

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-II

Exclusion Criteria:

  • Patients with uncontrolled hypertension, coronary artery disease or on beta blockers.
  • Cerebrovascular insufficiency.
  • Anaemia.
  • End stage renal failure.
  • Liver cirrhosis.
  • Patients with coagulopathy or receiving drugs influencing blood coagulation.
  • Pregnancy.
  • Known sensitivity to any of the study drugs.
  • Patients' refusal to participate in the study.

Sites / Locations

  • Ain Shams University Hospitals
  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Group I (control group)

Group II

Group III

Arm Description

Patients will be positioned supine.

patients will be positioned 10° anti-trendelenburg position.

patients will be positioned 20° anti-trendelenburg position.

Outcomes

Primary Outcome Measures

Quality of surgical field.
The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.
Surgical position accessibility.
The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.

Secondary Outcome Measures

Total dexmedetomidine consumption.
The total dose of dexmedetomidine used for each patient
Surgical time
duration of surgery (skin to skin time)
Recovery time
the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command
Sedation Score
Ramasay sedation score: will be assessed on arrival to the PACU, then every 30 min for the first 2 hours after surgery (1= anxious, agitation or restless; 2= cooperative, oriented, and tranquil; 3= responsive to commands; 4= asleep but with brisk response to light, glabellar tab, or loud auditory stimulus; 5= asleep, sluggish response to glabellar tab, or loud auditory stimulus; 6= asleep, no response).
Analgesia time
time to first rescue analgesic required

Full Information

First Posted
September 13, 2019
Last Updated
October 14, 2020
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT04095754
Brief Title
Can Head Position Improve Surgical Field During Ear Surgery?
Official Title
Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 12, 2020 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Middle ear surgeries utilizes microscope in a narrow field. They are better performed under controlled hypotension, to minimize bleeding and improve surgical field visualization and hence improve results.Head-up or anti-trendelenburg position influences intraoperative bleeding by generating regional ischaemia in sites elevated above the level of the heart. Also by augmenting the effect of vasodilators through pooling of blood in dilated veins.
Detailed Description
After obtaining local ethical committee approval and written informed consent from the patients, 225 adult patients, scheduled for elective middle ear surgery in Ain Shams University hospitals will be enrolled in this randomized, prospective controlled study. After applying basic monitors (ECG, pulse oximetry, non-invasive blood pressure monitoring and capnography), all patients will be premedicated with midazolam 0.02 mg.kg -1 IV and ranitidine 50 mg IV, 15 min. prior to surgery. All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1. Rate of infusion will be adjusted to maintain MAP 20% below baseline. Dexmedetomidine infusion will be stopped after graft insertion. Total dexmedetomidine consumption will be recorded. In the operating room and after 5 min preoxygenation, general anesthesia will be conducted using the same protocol for all patients: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation. Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim. Positive pressure ventilation will be set to maintain normocapnia. Patients will be randomly and evenly assigned to one of three groups, 75 patients each. Group I (control): Patients will be positioned supine. Group II: patients will be positioned 10° anti-trendelenburg position. Group III: patients will be positioned 20° anti-trendelenburg position. Randomization will be done using computer generated list. The anaesthesia nurse recording the data is blinded to the study groups. At the end of surgery, isoflurane will be discontinued and residual neuromuscular blockade will be reversed. Recovery time will be recorded (Defined as: the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command). Patients will then be transferred to PACU. During surgery, if the surgeon found it difficult to complete the surgery in the anti-trendelenburg (groups II and III), surgery will be continued in the supine position. Patients will still be calculated in the pre-assigned group with recording of such event, and assuming surgeon satisfaction to be 5 in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-operative Bleeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (control group)
Arm Type
Other
Arm Description
Patients will be positioned supine.
Arm Title
Group II
Arm Type
Experimental
Arm Description
patients will be positioned 10° anti-trendelenburg position.
Arm Title
Group III
Arm Type
Experimental
Arm Description
patients will be positioned 20° anti-trendelenburg position.
Intervention Type
Procedure
Intervention Name(s)
Head-Up Position
Other Intervention Name(s)
Anti-Trendelenburg Position
Intervention Description
Anti-Trendelenburg Position
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
controlled hypotension
Intervention Description
Controlled hypotension: All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1
Intervention Type
Drug
Intervention Name(s)
Induction and maintenance of anaesthesia
Other Intervention Name(s)
Anaesthetic drugs
Intervention Description
Induction of anaesthesia: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation. Maintenance:Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim.
Primary Outcome Measure Information:
Title
Quality of surgical field.
Description
The surgeon, as well as the surgeon's assistant, will be asked to assess the surgical field using a 5-point scale: 1- no bleeding, 2- minimal bleeding, 3- bleeding easily controlled, 4- bleeding hindering work, 5- bleeding stops work.
Time Frame
Immediately after surgery.
Title
Surgical position accessibility.
Description
The surgeon satisfaction concerning suitability of patient's position will be evaluated using a 5-point scale: 1- excellent, 2- good, 3- acceptable, 4- bad, 5- very bad.
Time Frame
Immediately after surgery.
Secondary Outcome Measure Information:
Title
Total dexmedetomidine consumption.
Description
The total dose of dexmedetomidine used for each patient
Time Frame
At the end of surgery
Title
Surgical time
Description
duration of surgery (skin to skin time)
Time Frame
At the end of surgery
Title
Recovery time
Description
the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command
Time Frame
At the end of surgery
Title
Sedation Score
Description
Ramasay sedation score: will be assessed on arrival to the PACU, then every 30 min for the first 2 hours after surgery (1= anxious, agitation or restless; 2= cooperative, oriented, and tranquil; 3= responsive to commands; 4= asleep but with brisk response to light, glabellar tab, or loud auditory stimulus; 5= asleep, sluggish response to glabellar tab, or loud auditory stimulus; 6= asleep, no response).
Time Frame
on arrival to the PACU, then every 30 min for the first 2 hours after surgery
Title
Analgesia time
Description
time to first rescue analgesic required
Time Frame
first 12 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I-II Exclusion Criteria: Patients with uncontrolled hypertension, coronary artery disease or on beta blockers. Cerebrovascular insufficiency. Anaemia. End stage renal failure. Liver cirrhosis. Patients with coagulopathy or receiving drugs influencing blood coagulation. Pregnancy. Known sensitivity to any of the study drugs. Patients' refusal to participate in the study.
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11588
Country
Egypt
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All primery and secondary outcome data
IPD Sharing Time Frame
After the publication of the study

Learn more about this trial

Can Head Position Improve Surgical Field During Ear Surgery?

We'll reach out to this number within 24 hrs