Skip to main content
OpenTrials
Completed

NCT Number: NCT04095754

Can Head Position Improve Surgical Field During Ear Surgery?

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University, Cairo, Egypt

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Head-Up Position

Procedure

Anti-Trendelenburg Position

Other names: Anti-Trendelenburg Position

Dexmedetomidine

Drug

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

Other names: controlled hypotension

Induction and maintenance of anaesthesia

Drug

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.

Other names: Anaesthetic drugs

Primary outcomes

  1. Quality of surgical field.

    Time frame: Immediately after surgery.

    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.

  2. Surgical position accessibility.

    Time frame: Immediately after surgery.

    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 outcomes

  1. Total dexmedetomidine consumption.

    Time frame: At the end of surgery

    The total dose of dexmedetomidine used for each patient

  2. Surgical time

    Time frame: At the end of surgery

    duration of surgery (skin to skin time)

  3. Recovery time

    Time frame: At the end of surgery

    the time from discontinuation of volatile anaesthetic till the patient is able to respond to verbal command

  4. Sedation Score

    Time frame: on arrival to the PACU, then every 30 min for the first 2 hours after surgery

    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).

  5. Analgesia time

    Time frame: first 12 hours after surgery

    time to first rescue analgesic required

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Can Anti-Trendelenburg Position Improve Surgical Field Without Affecting Accessibility During Ear Surgery? A Randomized-Controlled Trial.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.