AgitationNCT05165914
Midazolam Effect on Agitation Postnasal Surgery
A study testing Intravenous midazolam before emergence from general anesthesia and Intravenous normal saline before emergence from general anesthesia in people with Agitation, run by Jordanian Royal Medical Services at 1 site in Jordan.
Trial summary
Postoperative agitation is a common complication, it's incidence post head and neck surgery is around 11-26%. Avoiding such complication is mandatory to facilitate patient's recovery and reduce risk of postoperative agitation related complications. Read more about this study
- Who is it for?
- Ages 16 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation
- What is being tested?
- Intravenous midazolam before emergence from general anesthesia and Intravenous normal saline before emergence from general anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 27 May 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) of either grade 1 or 2.
- Age from 16 to 59 years.
- Patients undergoing nasal surgery such as; septoplasty (SP), open septo-rhinoplasty (OSRP) and functional endoscopic sinus surgery (FESS).
Who cannot join
- ASA grade more than 2.
- Age less than 16 or more than 59 years.
- Any surgery that doesn't involve the nose or sinuses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midazolam Effect on Agitation Postnasal Surgery: A Double Blinded Randomized Controlled Trial
Postoperative agitation is a common complication, it's incidence post head and neck surgery is around 11-26%. Avoiding such complication is mandatory to facilitate patient's recovery and reduce risk of postoperative agitation related complications. Our study aims to detect the incidence of agitation following nasal surgery, and to determine the midazolam effect on agitation, when administered just before emergence from anesthesia.
Read the detailed description
This is a prospective, single centre, double blinded randomized controlled trial, which was conducted from May 2021 to November 2021. An ethical approval was obtained from the local research ethical board in the Jordanian Royal Medical Services on May 26, 2021, in addition to an informed written consent from every patient. Subjects with American Society of Anesthesiologists (ASA) of either grade 1 or 2, aged from 16 to 59 years, undergoing nasal surgery such as; septoplasty (SP), open septorhinoplasty (OSRP) and functional endoscopic sinus surgery (FESS) were included in the study. A sample size of 100, 50 in each group was found to be enough to achieve the study purposes using G*Power computer program, considering alpha set at 0.05; medium effect size and study power 80%. Subjects were randomly assigned into two groups, midazolam group and placebo group. In the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia. On the other hand, placebo group's patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia. A computerized random number generator was utilized to provide the codes for midazolam and normal saline syringes. Patients otherwise received the same general anesthetic technique, including medications and equipments by the same anesthesiologist. The maximum Richmond Agitation Sedation Scale (RASS) score, from the time of extubation till patient's handover to postanesthesia care unit (PACU) was observed and documented by the same anesthesiologist and it was the basis for agitation diagnosis, therefore, the primary outcome was RASS score of +2 or more.
Anesthetic technique: No premedication was given to any patient. All patients received intravenous fentanyl 1.5 mcg.kg-1, propofol 2 mg.kg-1 and cisatracurium 0.2 mg.kg-1 for induction of general anesthesia. This was followed by manual ventilation for 4 minutes and intubation. Anesthesia was maintained by 1 MAC (Minimal Alveolar Concentration) of desflurane for all patients, in addition to remifentanil infusion (0.02 - 2.0 mcg.kg-1.minute-1) to aid analgesia and controlled hypotension with a mean arterial pressure not less than 60 mm Hg. An oropharyngeal pack was inserted for everyone and taken out gently before emergence and extubation. All patients received dexamethasone 8 mg, ondansetron 4 mg, 1 gram of paracetamol and 0.1 mg.kg-1 morphine intravenously. Morphine was given at the end of surgery by the time of turning the remifentanil infusion off. Midazolam or normal saline was randomly and blindly administered to patients using a 3 ml syringe (1mg.ml-1) at time of turning the remifentanil infusion off. By the end of surgery, desflurane was turned off and nobody received reversal for the cisatracurium, then smooth suctioning of the oral cavity was performed followed by awake extubation. No stimulation was used to aid patient's recovery except for gentle verbal commands.
- Conditions
- Agitation
- Being tested
- Intravenous midazolam before emergence from general anesthesia, Intravenous normal saline before emergence from general anesthesia
- Keywords
- Agitation, Midazolam, Nasal surgery, Emergence
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous midazolam before emergence from general anesthesiaDrug
Also called Versed
Intravenous administration of 0.03 mg/kg midazolam just before emergence from anesthesia.
Intravenous normal saline before emergence from general anesthesiaDrug
Also called Normal saline 0.9%
Intravenous administration of normal saline just before emergence from anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam group | Active comparator | In the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia. Receives: Drug: Intravenous midazolam before emergence from general anesthesia |
| Placebo group | Placebo comparator | In the placebo group, patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia. Receives: Drug: Intravenous normal saline before emergence from general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of agitation
Agitation is diagnosed using the maximum score of Richmond Agitation Sedation Scale (RASS)
Measured: Up to one hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start27 May 2021
- Primary completion25 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordanian Royal Medical Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Ben Tareef, Jordanian Royal Medical Services
- Investigators
- Ahmad Ben Tareef, MD, Principal investigator, Jordanian Royal Medical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165914
- Sponsor's protocol ID
- JordanianRoyalMS
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.
PubMed 23524149Kim KM, Lee KH, Kim YH, Ko MJ, Jung JW, Kang E. Comparison of effects of intravenous midazolam and ketamine on emergence agitation in children: Randomized controlled trial. J Int Med Res. 2016 Apr;44(2):258-66. doi: 10.1177/0300060515621639. Epub 2016 Feb 15.
PubMed 26880794Cho EJ, Yoon SZ, Cho JE, Lee HW. Comparison of the effects of 0.03 and 0.05 mg/kg midazolam with placebo on prevention of emergence agitation in children having strabismus surgery. Anesthesiology. 2014 Jun;120(6):1354-61. doi: 10.1097/ALN.0000000000000181.
PubMed 24566243Sherwin TS, Green SM, Khan A, Chapman DS, Dannenberg B. Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial. Ann Emerg Med. 2000 Mar;35(3):229-38. doi: 10.1016/s0196-0644(00)70073-4.
PubMed 10692189
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam Effect on Agitation Postnasal Surgery: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05165914
- Acronym / sponsor ID
- JordanianRoyalMS
- Conditions
- Agitation
- Keywords
- Agitation, Midazolam, Nasal surgery, Emergence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jordanian Royal Medical ServicesUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative agitation is a common complication, it's incidence post head and neck surgery is around 11-26%. Avoiding such complication is mandatory to facilitate patient's recovery and reduce risk of postoperative agitation related complications. Our study aims to detect the incidence of agitation following nasal surgery, and to determine the midazolam effect on agitation, when administered just before emergence from anesthesia.
Detailed description
This is a prospective, single centre, double blinded randomized controlled trial, which was conducted from May 2021 to November 2021. An ethical approval was obtained from the local research ethical board in the Jordanian Royal Medical Services on May 26, 2021, in addition to an informed written consent from every patient. Subjects with American Society of Anesthesiologists (ASA) of either grade 1 or 2, aged from 16 to 59 years, undergoing nasal surgery such as; septoplasty (SP), open septorhinoplasty (OSRP) and functional endoscopic sinus surgery (FESS) were included in the study. A sample size of 100, 50 in each group was found to be enough to achieve the study purposes using G*Power computer program, considering alpha set at 0.05; medium effect size and study power 80%. Subjects were randomly assigned into two groups, midazolam group and placebo group. In the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia. On the other hand, placebo group's patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia. A computerized random number generator was utilized to provide the codes for midazolam and normal saline syringes. Patients otherwise received the same general anesthetic technique, including medications and equipments by the same anesthesiologist. The maximum Richmond Agitation Sedation Scale (RASS) score, from the time of extubation till patient's handover to postanesthesia care unit (PACU) was observed and documented by the same anesthesiologist and it was the basis for agitation diagnosis, therefore, the primary outcome was RASS score of +2 or more.
Anesthetic technique: No premedication was given to any patient. All patients received intravenous fentanyl 1.5 mcg.kg-1, propofol 2 mg.kg-1 and cisatracurium 0.2 mg.kg-1 for induction of general anesthesia. This was followed by manual ventilation for 4 minutes and intubation. Anesthesia was maintained by 1 MAC (Minimal Alveolar Concentration) of desflurane for all patients, in addition to remifentanil infusion (0.02 - 2.0 mcg.kg-1.minute-1) to aid analgesia and controlled hypotension with a mean arterial pressure not less than 60 mm Hg. An oropharyngeal pack was inserted for everyone and taken out gently before emergence and extubation. All patients received dexamethasone 8 mg, ondansetron 4 mg, 1 gram of paracetamol and 0.1 mg.kg-1 morphine intravenously. Morphine was given at the end of surgery by the time of turning the remifentanil infusion off. Midazolam or normal saline was randomly and blindly administered to patients using a 3 ml syringe (1mg.ml-1) at time of turning the remifentanil infusion off. By the end of surgery, desflurane was turned off and nobody received reversal for the cisatracurium, then smooth suctioning of the oral cavity was performed followed by awake extubation. No stimulation was used to aid patient's recovery except for gentle verbal commands.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam group | Active comparator | Drug: Intravenous midazolam before emergence from general anesthesiaIn the midazolam group, patients double blindly received 0.03 mg.kg-1 midazolam intravenously just before emergence from general anesthesia. |
| Placebo group | Placebo comparator | Drug: Intravenous normal saline before emergence from general anesthesiaIn the placebo group, patients double blindly received normal saline of similar volume to midazolam just before emergence from general anesthesia. |
Who may qualify
- Ages
- 16 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) of either grade 1 or 2.
- Age from 16 to 59 years.
- Patients undergoing nasal surgery such as; septoplasty (SP), open septo-rhinoplasty (OSRP) and functional endoscopic sinus surgery (FESS).
Key exclusion criteria (3 listed)
- ASA grade more than 2.
- Age less than 16 or more than 59 years.
- Any surgery that doesn't involve the nose or sinuses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous midazolam before emergence from general anesthesiaAlso: VersedIntravenous administration of 0.03 mg/kg midazolam just before emergence from anesthesia. | Drug | Midazolam group |
| Intravenous normal saline before emergence from general anesthesiaAlso: Normal saline 0.9%Intravenous administration of normal saline just before emergence from anesthesia. | Drug | Placebo group |
Primary outcome
Development of agitation
Time frame: Up to one hour after extubation
Agitation is diagnosed using the maximum score of Richmond Agitation Sedation Scale (RASS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Results publication: PubMed 23524149Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.
- Results publication: PubMed 26880794Kim KM, Lee KH, Kim YH, Ko MJ, Jung JW, Kang E. Comparison of effects of intravenous midazolam and ketamine on emergence agitation in children: Randomized controlled trial. J Int Med Res. 2016 Apr;44(2):258-66. doi: 10.1177/0300060515621639. Epub 2016 Feb 15.
- Results publication: PubMed 24566243Cho EJ, Yoon SZ, Cho JE, Lee HW. Comparison of the effects of 0.03 and 0.05 mg/kg midazolam with placebo on prevention of emergence agitation in children having strabismus surgery. Anesthesiology. 2014 Jun;120(6):1354-61. doi: 10.1097/ALN.0000000000000181.
- Results publication: PubMed 10692189Sherwin TS, Green SM, Khan A, Chapman DS, Dannenberg B. Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial. Ann Emerg Med. 2000 Mar;35(3):229-38. doi: 10.1016/s0196-0644(00)70073-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Ben Tareef, MD principal investigator
Jordanian Royal Medical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous midazolam before emergence from general anesthesia and Intravenous normal saline before emergence from general anesthesia in people with Agitation, run by Jordanian Royal Medical Services at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of agitation (time frame: Up to one hour after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05165914, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.